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About Nucleus Biologics:

At Nucleus Biologics, we are passionate about supporting the development of groundbreaking discoveries and improving the quality of life for patients. Our cell culture products and services fuel today’s therapies and tomorrow’s innovations.

Cell culture media is a critical raw material used in the development of cell-based projects. As the Cell Performance Company™, we are the leading provider of custom cell growth media, tools, and technologies that support every stage of development from research through commercialization. We are committed to delivering premium products and services through a transparent, consistent, and proven supply chain that eliminates variability.

About the role

This role will be primarily responsible for driving Core Product Development Initiative, including implementing internal product/process development to support robust customer portfolios. This position will report to Associate Director, MSAT.

What you'll do

Tech Transfer and onboarding of incoming upstream projects (including Process Performance Validations, Technical Design for Validations, and product FMEAs)
Drive Core Product Development Initiatives and scale up
Develop and Review manufacturing Batch Records
Generate and execute process development studies and technical documentation base on results
Drive pilot test runs in preparation for onboarding projects
Develop and improve current and new manufacturing processes
Work with software engineers to develop automated systems
Support Project management group with technical support and communication during customer onboarding
Facilitate clear communication with cross-functional Core Team and stakeholders
Support integration of regulatory requirements during product commercialization
Collect and generate data to support analysis for strategic upstream decision making
Rapid TAT for evaluating onboarding of new projects during feasibility
Have fun and contribute to a winning culture

Qualifications

EDUCATION:

Requires a BS or MS degree in Chemistry, Biochemistry, Organic Chemistry, Chemical Engineering or related field
BS degree: 4+ years of related experience
MS degree: 3+ years of related experience

REQUIRED EXPERIENCE:

Must thrive in a fast paced, start-up environment and must be able to meet critical deadlines
Previous work experience in life science, pharma or biotech industries preferred Ability to self-manage multiple projects and priorities simultaneously
Previous experience with new product introduction and commercialization
Development of SOPs, BRs, WI
Strong fundamental knowledge in chemistry
Hands-on experience handling lab equipment, mixers, pH meter, Osmometer, conductivity meters
Proficient in understanding Good Manufacturing Practices (GMP) and how GMP applies to the development of a process
Intermediate to advanced skills in Word, Excel and PowerPoint
Detail-oriented and process driven
Strong Problem solving and decision making skills
Good written and oral communication skills
General understanding of software systems and AI language models is a plus
Familiarity with ISO 13485 a plus

PHYSICAL REQUIREMENTS:

Ability to hear and speak to employees and external associates on the phone and in person
Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision)
Ability to lift 30 lbs. to a height of 3-4 feet on a regular basis

TRAVEL REQUIREMENTS:

May require travel to and from Nucleus Biologics offices or customer/vendor locations based on position.

NOTE: The above statements are intended to describe the general nature and level of work being performed by incumbents. They are not intended to be an exhaustive list of all responsibilities, duties and skills required by all incumbents. Incumbents may perform other duties as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Management retains the right to add to or change the duties of the position at any time.

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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

Join us in creating a future where diseases are no longer a concern! Johnson & Johnson Innovative Medicine in Schaffhausen (Cilag AG) specializes in the production of pharmaceuticals and active ingredients. The Schaffhausen site plays a strategic role in launching and growing some of Johnson & Johnson's key pharmaceutical products. Utilizing advanced technologies and processes, this site manufactures a variety of pharmaceutical dosage forms and chemical active ingredients. We are currently looking for a Senior Cleaning Validation Engineer in MSAT (Manufacturing, Science & Technology) Biotherapeutics to enhance our team.

POSITION SUMMARY:

As an MSAT Experienced Validation Engineer, you will be responsible, alongside other team members, for developing, maintaining, and preparing reliable Equipment sterilization and decontamination processes for the parenteral fill finish production to meet future requirements. This involves collaborating in cross-functional teams within the site and exchanging knowledge with other locations worldwide.

KEY RESPONSIBILITIES:

Develop and validate sterilization and decontamination processes.
Develop and validate improved sterilization and decontamination processes.
Develop and implement new strategies for Equipment process validation (EPV).
Propose and support technical improvements to equipment and processes.
Create documents for equipment process validation activities (protocols, reports, risk assessments, SOPs).
Coordinate EPV validation activities with other departments.
Lead and participate in investigations and change controls.
Prepare technical assessments for investigations and change controls.
Represent MSAT in cross-departmental projects and global meetings.
Maintain an excellent partnership with all business partners at the site and within J&J.
Present Equipment process validation during audits/inspections.
Contribute to the digital transformation of MSAT (e.g., digitization and automation of reports, data management, visualization, evaluation of new technologies).

Qualifications:

As an ideal candidate, you have:

A Bachelor’s or Master’s degree in Life Sciences or Engineering.
At least 2 years of experience in the pharmaceutical industry.
Experience in Sterilization / decontamination validation (operations, engineering, quality department, etc.).
Led investigations and change control projects.
Experience in project management.

You are:

Proficient in German and English, both in communication and negotiation.
Customer-oriented and quality-conscious.
Strong in decision-making and problem-solving.
An innovative team player who can propose creative and pragmatic solutions.
Able to work in a complex global matrix organization with multiple stakeholders.
Interested in digital transformation and capable of proposing and implementing corresponding process improvements.

We offer:

A versatile challenge in a dynamic, international environment with attractive conditions and career opportunities, as well as good infrastructure at the Schaffhausen site.
Many opportunities to work on exciting projects and assignments.
Support for childcare.
A wide range of training opportunities for personal and professional development.
Attractive benefits from the Johnson & Johnson pension scheme in Switzerland.

A variety of perks for insurance, products, sports, culture, and much more.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The MSAT Engineer ensures that all GMP manufacturing processes are crafted and delivered in a compliant and efficient manner. This role supports the technical and regulatory aspects of assigned projects from inception to completion, including tech transfer and scale-up activities. The engineer collaborates cross-functionally across the organization to facilitate successful project completion aligned with Lonza’s goals.

Key responsibilities:

Offer technical assistance for all GMP manufacturing processes and projects.
Lead and support technology transfer activities from development to GMP manufacturing, including scale-up and risk mitigation for tablet formulations.
Plan, coordinate, review, and track timelines and progress to ensure timely deliverables.
Apply knowledge in blending, granulation, encapsulation, tableting, and coating operations.
Offer technical assistance for GMP oral solid dose (OSD) manufacturing operations.
Understand and apply chemical and engineering fundamentals including chemistry, materials science, and basic mathematical modeling.
Author documentation including master batch records, protocols, and engineering studies.
Collaborate with internal departments and clients to develop and optimize manufacturing processes.
Lead process and technical investigations to support root cause analysis, product impact assessment, and effective CAPA definition.
Perform and interpret statistical analyses such as SPC, multiple linear regression, ANOVA, and multivariate analysis.
Apply Building of Experiments (BoE) principles during early clinical phase development to support robust process construction.

Key requirements:

Minimum Education Level Required: Bachelor’s degree or equivalent experience
Desired Area of Study: Science or Engineering
Minimum Years of Experience: 1–3 years
Desired Area of Expertise: Pharmaceutical sector with familiarity in cGMP standards
Attend applicable meetings and discussions in support of related projects.
Align with all state and federal regulatory requirements and guidelines.
Follow all specified Safety and Sustainability guidelines and ask for clarification when necessary.
Promptly report and rectify Safety and Sustainability issues or deficiencies.
Stop work when necessary to maintain safety.

Compensation for the role will depend on a number of factors, including the successful candidate’s qualifications, skills, competencies, experience, and job-related knowledge. Full-time employees receive a comprehensive benefits package including performance-related bonus, medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

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Company Description

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

Job Description

Job Summary
\nWe are seeking a dynamic and experienced Team Lead in Process Development to lead and guide the Injectable Process development team in areas of Quality by Design (QbD), Process selection, Scale Up and Technology transfer to Manufacturing, Science & Technologies (MSAT)/ Formulation Technology Organisation (FTO)/ Contract Manufacturing Organisation (CMO) and ensure product development leads to development of robust manufacturing process throughout the clinical phases and commercial product life cycle.
\n
\nRoles & Responsibilities
\n

Technology Transfer, Troubleshooting & Continuous Improvement

Prepare, review, and approve technical protocols, reports, SOPs, and product impact assessments related to product lifecycle management (LCM).
Initiate, review, and approve change controls, incidents, and risk assessments related to validation and qualification activities.
Coordinate with cross-functional teams (Production, QA, QC) for execution and documentation of new products, scale-ups, and transfers.
Lead technology transfer activities for new products, scale-ups, line transfers, and site-to-site commercial batches for injectable products.
Support investigations for non-conformances (Incidents, OOS, OOT, Market Complaints) through root cause analysis and impact assessments.
Provide technical support for process changes and improvements along with addressing regulatory deficiencies and support audits to ensure timely product approvals.
Serve as a technical expert to resolve domain-specific issues and contribute to organizational problem-solving.
Review Continued Process Verification (CPV) assessments and Product Quality Reports (PQRs).

Cleaning Validation: Prepare and review cleaning validation documents including protocols, reports, master plans, and assessments.

Analytical Support:

Provide technical support to the analytical team in designing and reviewing analytical methods for quality and compliance.
Evaluate and introduce new analytical technologies to resolve technical issues, perform proof of concept, and support HPT initiatives.

Subject Matter Expertise: Serve as the subject matter expert for fill-finish processes, ensuring robust and compliant operations.

Qualifications

Educational qualification: Bachelors/ Master in Pharmacy
\n
\nMinimum work experience: 6-9 years of Experience and at least 4 years of experience in Drug product tech transfers & operations support (DP-MSAT) in Pharmaceutical industry.
\n
\nSkills & attributes:
\nTechnical Skills
\n• Handled various forms of injectables which includes lyo products, complex injectables and liquid injections.
\n• Knowledge of the technology transfers from site to site and R&D to operations.
\n• Knowledge in Six Sigma Lean Techniques (Preferred).
\n• Knowledge about Good Documentation practices (GDP) and Good Manufacturing Practice (GMP).
\n
\nBehavioural skills

• Good Interpersonal skills and capacity to work collaboratively with cross-functional teams, like R&D, manufacturing, SCM, quality assurance, regulatory affairs, and others.
\n• Strong analytical and problem-solving skills to address challenges.
\n• Demonstrates integrity by consistently following protocols, exhibiting trustworthiness and reliability.
\n• Takes responsibility and maintains a disciplined and agile approach to execution.

Additional Information

About the Department

Integrated Product Development Organisation

Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.
\nBenefits Offered
\nAt Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
\nThe benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.
\n
\nOur Work Culture
\nAsk any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
\nFor more details, please visit our career website at https://careers.drreddys.com/#!/

Catalent Pharma Solutions est un groupe américain, considéré comme le premier fournisseur de services externalisés et de technologies exclusives pour les industries pharmaceutiques et de biotechnologie, auxquelles il apporte son expertise et sa capacité d'innovation dans le développement, la production et le conditionnement de produits pharmaceutiques.

Le site de Limoges, avec une expertise reconnue dans le domaine du remplissage aseptique, développe actuellement un Centre d'Excellence en Biotechnologie pour le marché européen centré sur les activités cliniques (phase 1 à 3) et commerciales. Le site proposera, en plus des activités de remplissage et de finition, la formulation de médicaments biologiques et le développement de procédés, ainsi que le développement de progiciels analytiques de pointe pour caractériser et contrôler les produits biologiques.

C'est dans ce contexte que nous recherchons actuellement un renfort en CDI:

Ingénieur MSAT - Produits pharmaceutiques biologiques.

Aperçu du poste

L'ingénieur en sciences et technologies de fabrication est responsable du soutien technique de la fabrication, y compris le transfert entre les clients externes ou le département de développement des processus de produits pharmaceutiques et la fabrication.

L'ingénieur en sciences et technologies de fabrication soutient l'adaptation des installations et le transfert technique du processus de fabrication de produits pharmaceutiques biologiques, y compris l'évaluation, l'alignement et la recommandation d'améliorations de l'équipement et du processus. Ce rôle consiste également à diriger le soutien technique de la fabrication. Il est responsable de l'introduction de nouveaux produits et de l'adaptation des processus avec le développement de systèmes à usage unique et d'emballages primaires/secondaires.

L'ingénieur MSAT conduit l'analyse des écarts, l'analyse des installations pour les nouveaux produits, les protocoles de transfert et compile les données de processus, et fournit des données techniques dans les enquêtes sur les écarts, les contrôles de changement et les CAPA.

L'ingénieur MSAT peut être amené à rencontrer des clients lors de réunions techniques et à travailler en collaboration avec eux pour faire avancer les projets ; il sera le back-up du manager pour les aspects commerciaux si nécessaire.

Vos missions:

Travailler de manière transversale avec le client, les chefs de projet, le développement des produits pharmaceutiques, la fabrication, l'assurance qualité, le contrôle de la qualité…
Définir et mettre en œuvre des solutions pour l'introduction de nouveaux produits.
Conception, développement et rédaction de rapports pour les lots techniques et GMP
Fournir une assistance technique pour les lots des clients
Préparer la compilation des données relatives aux processus, y compris la communication de l'état d'avancement du projet et la réalisation de présentations internes et à l'intention des clients.
Évaluation des processus existants et identification des améliorations à apporter aux processus et/ou aux équipements afin d'améliorer l'efficacité, la cohérence et la compétitivité sur le marché.
Compétences et intérêt marqué pour les statistiques et pour la réalisation d'analyses de processus et/ou de données expérimentales. La connaissance des méthodes avancées et des outils informatiques correspondants est souhaitée (par exemple, l'analyse de données multivariées, le contrôle statistique des processus, la conception d'expériences).
Rédiger et réviser des documents techniques, y compris des dossiers de lots maîtres (MBR), des spécifications, des rapports de projet et des spécifications techniques.
Fournir un soutien technique pour les déviations, les contrôles de changement et les CAPA.

Votre profil:

Bac+5, Pharmacien ou Ingénieur en génie des procédés, en biotechnologie ou dans une discipline étroitement liée avec au moins 3 ans d'expérience pertinente dans l'industrie pharmaceutique
Solide expérience dans le traitement des formes parentérales de médicaments biologiques, avec une connaissance de la qualité pharmaceutique et des BPF (bonnes pratiques de fabrication).
Connaissance avérée des systèmes à usage unique pour la formulation, le remplissage et l'interaction des produits.
Connaissance du conditionnement primaire et secondaire
Expérience du remplissage aseptique sous isolateur.
Connaissance pratique avérée du transfert de technologie (interne et externe) entre le développement et la fabrication.
Expérience souhaitée en matière de Quality by Design et ICHQ8.
Capacité avérée à résoudre des problèmes techniques complexes et à diriger des équipes interfonctionnelles dans l'analyse et la prise de décision.
Solides compétences interpersonnelles et de présentation pour discuter des concepts techniques en interne et avec les clients.
Notions de statistique
La connaissance de la validation des processus sera un plus
Maitrise de l'anglais
Orientation client
Excellentes aptitudes à la communication écrite et orale, ainsi qu'à la présentation.
Esprit \"Think out of the box\".
Esprit d'équipe
Souci du détail et des processus

Catalent offer des opportunités enrichissantes pour faire avancer votre carrière! Rejoignez le leader mondial du développement et de la production de médicaments et aidez-nous à proposer plus de 7 000 produits qui sauvent et améliorent la vie des patients du monde entier. Catalent est une société internationale passionnante et en pleine croissance où les employés travaillent directement avec des sociétés pharmaceutiques, biopharmaceutiques et de santé grand public de toutes tailles pour faire progresser de nouveaux médicaments, du développement précoce aux essais cliniques et à la mise sur le marché. Catalent produit plus de 70 milliards de doses par an, et chacune sera utilisée par quelqu'un qui compte sur nous. Rejoignez-nous pour faire la différence.

Initiative personnelle. Rythme dynamique. Un travail significatif.

Visitez Catalent Careers pour explorer les opportunités de carrière.

Catalent est un employeur garantissant l'égalité des chances et ne fait aucune discrimination sur la base d'une caractéristique protégée par la législation locale.

Si, en raison d’un handicap, vous avez besoin d'un aménagement raisonnable pour une partie ou plus du processus de candidature ou d'embauche, vous pouvez soumettre votre demande en envoyant un courriel et en confirmant votre demande d'aménagement et en incluant le numéro de poste, le titre et le lieu à DisabilityAccommodations@catalent.com. Cette option est réservée aux personnes ayant besoin d'un aménagement en raison d'un handicap. Les informations reçues seront traitées par un employé de Catalent aux États-Unis, puis acheminées vers un recruteur local qui fournira une assistance pour assurer une prise en compte appropriée dans le processus de candidature ou d'embauche.

Avis aux représentants des agences et des cabinets de recherche : Catalent Pharma Solutions (Catalent) n'accepte pas les curriculum vitae non sollicités d'agences et/ou de cabinets de recherche pour cette offre d'emploi. Les curriculum vitae soumis à tout employé de Catalent par une agence tierce et/ou une société de recherche sans un accord de recherche écrit et signé valide, deviendront la propriété exclusive de Catalent. Aucuns frais ne seront payés si un candidat est embauché pour ce poste à la suite d'une recommandation non sollicitée d'une agence ou d'un cabinet de recherche. Merci.

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Use Your Power for Purpose

Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our flexible, innovative, and customer-oriented quality culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of our work.

What You Will Achieve

In this role, you will:

Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with regulatory requirements and company policies.
Troubleshoot validation problems for equipment and performance processes, conducting statistical analysis of testing results to address process anomalies.
Write, review, and approve validation process documents and technical reports related to equipment, products, and processes.
Contribute to project tasks and milestones, organizing work to meet deadlines and applying basic team effectiveness skills within the immediate Work Team.
Make decisions within limited options to resolve basic problems, working under the supervisor's direction and seeking guidance from colleagues.
Ensure work is regularly reviewed for technical judgment, completeness, and accuracy, exercising judgment with reliance on the supervisor.
Determine the process capability of new equipment through the execution of approved protocols, incorporating defined parameters into operating procedures and batch records.
Assist with the development of validation protocols, manage regulatory queries and responses, and participate in deviation investigations to identify root causes and define corrective and preventative actions.
Adhere to all company and Good Manufacturing Practices (cGMP) procedures, safety regulations, and participate in the development of validation programs to stay current with cGMPs and industry standards.
Work effectively as a member of the Quality Operations (QO) cGMP training team, collaborating with Business Area Training Leads, Coordinators, and SMEs to support cGMP and site training initiatives, reporting to the Validation Section Manager and summarizing data into concise reports for review and approval.

Here Is What You Need (Minimum Requirements)

Applicant must have a bachelor's degree with 4 years of experience, or an associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience
Excellent attention to detail and a solid understanding of Food and Drug Administration Regulations/Guidance and Good Manufacturing Practices
Strong organizational skills and the ability to manage changing deadlines
Proficiency in Microsoft Office, particularly Excel, for data evaluation
Strong written and verbal communication skills
Ability to work in a team environment and collaborate effectively with colleagues
Basic understanding of validation principles and practices

Bonus Points If You Have (Preferred Requirements)

Technical writing experience, particularly within the pharmaceutical industry
Laboratory process validation expertise
Working knowledge of equipment qualification and calibration, especially for laboratory equipment
Experience with regulatory queries and responses
Excellent interpersonal skills and the ability to work collaboratively with cross-functional teams
Adaptability and flexibility in a dynamic work environment
Commitment to continuous learning and professional development

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control

","hiringOrganization":{"@type":"Organization","name":"Pfizer","sameAs":"https://www.pfizer.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"IND - Vizag, India","addressCountry":"India","addressRegion":"Asia/Pacific"}}}},{"@type":"ListItem","position":7,"item":{"@type":"JobPosting","title":"Director, MSAT","datePosted":"2025-08-31","description":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The Director, MSAT is responsible for leading the Manufacturing Science and Technology team within the Orca organization. This role oversees manufacturing processes as they transfer from development into commercial operations and throughout the commercial lifecycle of the product. The Director, MSAT works closely with teams, such as Development, Quality, Operations, Regulatory Affairs and CMC to launch, scale-up and optimize operational attributes to ensure product quality, efficiency and compliance with regulatory standards. This position requires on-site attendance at our Sacramento facility.\n

Physical Demands

Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.

Work Conditions

Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
Must be comfortable regularly participating in video-based meetings.
May be required to work scheduled overtime, weekends, or holidays based on business needs.

Responsibilities

Lead a team of scientists, engineers and technical experts to support the launch, scale up and maintenance of late stage and commercial manufacturing processes
Establish and maintain performance metrics to measure manufacturing operations.
Develop strategies to enhance manufacturing processes, including optimizing processes for investigation, corrective actions and change management for MSAT Projects
Implement process improvements based on data analysis and scientific principles including focus on technology, alternate materials, shipping and labeling, and data from continuous process verification
Drive the execution of various studies, qualifications and design of experiments related to deviations, process performance, and regulatory needs for commercial products.
Develop and drive practices for the transfer of processes from development into commercial manufacturing facilities
Coordinate with the operations team to ensure successful implementation of new processes in commercial GMP environments
Collaborate with cross functional teams to trouble shoot and resolve technical issues
Lead and drive the preparation and review of data to support regulatory submissions
Build and mentor the MSAT team ensure the team is equipped with the skills and tools to meet current and future manufacturing needs

Education & Experience Requirements

B.S. in Engineering, Chemistry, Pharmacy or related scientific discipline required
PhD in Chemical Engineering, Biochemistry or Analytical Chemistry is preferred
Minimum of 10 years of experience, with demonstrated success in higher-level decision-making roles
Experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries
4+ years of people leadership experience
Prior experience in regulated, GMP manufacturing operations
Strong communication and problem-solving skills
Experience in Cell therapy manufacturing preferred
Knowledge of automation, continuous process verification, investigation processes, process optimization

Personal Qualities & Physical Demands

Highly detail oriented with special attention to quality, compliance and safety
Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
Strong interpersonal skills and ability to communicate effectively
Ability to work in a collegial and collaborative manner, independently and part of a team
Ability to work in a fast-paced start-up environment while following SOPs
Highly tolerant and respectful of all team members
Strong problem-solving skills with desire to improve upon established processes
Ability to work in cleanroom environments and, at times, across various shifts
Ability to follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition
Occasional need to ascend/descend stairs within workspace; job requires standing/walking

The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to competitive medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.","hiringOrganization":{"@type":"Organization","name":"Orca Bio","sameAs":"https://orcabio.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Sacramento, CA","addressCountry":"United States","addressRegion":"North America"}}}},{"@type":"ListItem","position":8,"item":{"@type":"JobPosting","title":"MSAT Specialist","datePosted":"2025-09-05","description":"

Company Description

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

Job Description

Technology Transfer, Troubleshooting & Continuous Improvement

Prepare, review, and approve technical protocols, reports, SOPs, and product impact assessments related to product lifecycle management (LCM).
Initiate, review, and approve change controls, incidents, and risk assessments related to validation and qualification activities.
Coordinate with cross-functional teams (Production, QA, QC) for execution and documentation of new products, scale-ups, and transfers.
Lead technology transfer activities for new products, scale-ups, line transfers, and site-to-site commercial batches for injectable products.
Support investigations for non-conformances (Incidents, OOS, OOT, Market Complaints) through root cause analysis and impact assessments.
Provide technical support for process changes and improvements along with addressing regulatory deficiencies and support audits to ensure timely product approvals.
Serve as a technical expert to resolve domain-specific issues and contribute to organizational problem-solving.
Review Continued Process Verification (CPV) assessments and Product Quality Reports (PQRs).

Cleaning Validation: Prepare and review cleaning validation documents including protocols, reports, master plans, and assessments.

Analytical Support:

Provide technical support to the analytical team in designing and reviewing analytical methods for quality and compliance.
Evaluate and introduce new analytical technologies to resolve technical issues, perform proof of concept, and support HPT initiatives.

Subject Matter Expertise: Serve as the subject matter expert for fill-finish processes, ensuring robust and compliant operations.

Qualifications

Additional Information

About the Department

Integrated Product Development Organisation

","hiringOrganization":{"@type":"Organization","name":"Dr. Reddy's Laboratories","sameAs":"https://www.drreddys.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Pydibimavaram, AP, India","addressCountry":"India","addressRegion":"Asia/Pacific"}}}},{"@type":"ListItem","position":9,"item":{"@type":"JobPosting","title":"Sr MSAT Associate","datePosted":"2025-08-07","description":"With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

We are seeking an experienced and highly skilled MSAT Scientist with deep expertise in bioconjugation processes, including Antibody-Drug Conjugates (ADCs) and Antibody-Oligonucleotide Conjugates (AOCs), to support our clinical and commercial manufacturing operations. This position plays a critical role in bridging process development and GMP manufacturing, ensuring successful tech transfer, process robustness, and manufacturing readiness for highly potent and complex biologic-drug conjugates.\n

Responsibilities

Adhere to all GDP, GLP, and cGMP requirements as well as Abzena policies, procedures, and mission while fulfilling duties, responsibilities, and tasks.
Display understanding of USP, 21 CFR, and ICH guidelines.
Serve as the MSAT subject matter expert (SME) for bioconjugation processes including ADCs and AOCs across early development through commercial lifecycle stages.
Provide technical leadership for tech transfer from process development to GMP manufacturing, including facility fit, risk assessments, and process scale-up.
Drive Technology Transfer into cGMP Manufacturing from internal or external process development teams
Author and revise GMP-compliant batch records and master batch production documents for early-phase, late-phase, and commercial programs.
Draft addition GMP documents including: BOMs, Specifications, SOPs, Tech Transfer Documents, PFDs, and P&IDs.
Lead or support process investigations, deviations, CAPAs, and root cause analysis related to conjugation, UF/DF, and chromatography operations.
Provide in-person and real time manufacturing production support required for project success.
Drive continuous improvement initiatives related to process robustness, documentation, and manufacturing efficiency.
Design and implement process characterization, scale-up, and control strategies in collaboration with PD, Manufacturing, and QA/QC teams.
Maintain a strong working knowledge of cGMP raw materials, consumables, assemblies, in-process materials, designs, and part numbers to complete detailed cGMP records.
Participate in or lead PPQ campaigns, including planning, execution support, and regulatory documentation contributions.
Support regulatory inspections, client audits, and due diligence as the MSAT technical lead.
Contribute to cross-functional project teams to deliver clinical and commercial batches of bioconjugates on time and within scope.
Demonstrates technical proficiency, scientific creativity, and collaboration with others.
Operate to the highest ethical and moral standards.
Ability to multi-task, supporting multiple projects simultaneously ensuring all deadlines are on budget and on time.
Discuss and present manufacturing campaign data and analysis to internal project teams and respective clients
Perform other duties as assigned.

Required Qualifications

PhD or MS in Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline
5+ years of experience in biopharma MSAT or technical operations, with a focus on ADC and/or AOC processes.

Knowledge

Proven track record in both development and commercial-stage support, including batch record authorship and process documentation.
Working knowledge of GMP operations, including manufacturing floor support, deviation resolution, and change control.
Knowledge and skill with aseptic technique required: BSC Operations, and aseptic processing, including welding/sealing and/or single use sterile connectors
Hands-on experience with conjugation chemistries, tangential flow filtration (TFF), Protein A, ion exchange (IEX), and hydrophobic interaction chromatography (HIC).
Strong understanding of Microsoft Office Suite including basic functions and graphing within Microsoft Excel
Familiarity with semi/fully automated manufacturing equipment
Proven ability to troubleshoot bioprocess operations and equipment.
Understanding of relevant analytical, processing, and scale-up calculations.
Proven ability to build, modify, and utilize digital data storage, visualization, and analysis systems/tools.
Strong interpersonal and communication skills, with the ability to interface effectively with cross-functional teams and clients

Preferred Qualifications

Experience with Contact Manufacturing Company (CMC)
Experience with high-potency APIs and handling OEB 4–5 level materials.
Familiarity with process validation (PPQ), commercial tech transfer, and lifecycle management.
Understanding of ICH, FDA, and EMA regulatory expectations for complex biologics and bioconjugates.

FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.","hiringOrganization":{"@type":"Organization","name":"Abzena","sameAs":"https://www.abzena.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bristol, PA","addressCountry":"United States","addressRegion":"North America"}}}},{"@type":"ListItem","position":10,"item":{"@type":"JobPosting","title":"MSAT Principle Scientist","datePosted":"2025-08-08","description":"

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Job Description

MSAT Principal Scientist

Johnson and Johnson Innovative Medicines is recruiting for the Advanced Therapies Manufacturing Science and Technology (MSAT) organization! We are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. Are you interested in joining a team that is positively impacting patients' lives by growing and scaling our high-quality cell, gene therapy and targeted radioligand therapy products? Apply today for this exciting opportunity to be part of the team! Location Sassenheim (The Netherlands) or Raritan, NJ (USA).

The Principal Scientist we are looking for is responsible for leading complex, global investigations and improvement and harmonization projects across the lentiviral vector production network of the Advanced Therapies Supply Chain for life saving drugs and/or drugs with high unmet medical need. You will also be responsible for Life-Cycle Management projects that will drive reliability, innovation and sustainability in our processes and manufacturing plants, both internally and externally. In this role, you will partner with R&D, Quality, and Regulatory to ensure processes meet the needs of today and tomorrow. The Principal Scientist will work in close collaboration with other global and local roles and must have strong communication skills to influence other functions and management levels outside of their own group. In this role you will effectively lead global and cross-organizational teams to generally attain desired results for all parties. Solid technical understanding in cell and gene therapy manufacturing processes under GMP conditions is a must. Hands-on experience in both R&D and Manufacturing Operation is highly desirable.

Key Responsibilities:

Lead complex and global investigations with cross-functional teams.
Connect closely with site manufacturing and support teams to ensure manufacturing and supply demands are met.
Lead projects that will enhance manufacturing output through optimization and harmonization across production sites. Your efforts will have a direct impact on patient supply!
Identify and implement new technologies; focus on decrease in COGs, partner with R&D and JSC groups to develop and implement strategies to improve the fit for plant and commercialization of new products into the supply chain.
Contribution, review and approval of the product technical and regulatory documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc.)

Qualifications

Required:

Master’s degree in engineering or Equivalent with 8-10 years work experience. PhD degree preferred.
Detailed technical knowledge of biopharmaceutical manufacturing site unit operations (DS and/or DP) under GMP conditions.
Demonstrated competency and experience leading complex investigations with cross-functional teams.
Ability to influence and lead peers, superiors, and external partners.

Preferred:

Experience with (lenti)viral vector products and production under (BSL-2) BioSafety conditions.
Knowledge of manufacturing site systems and procedures (SAP, event and complaint handling, change control, qualification, Process Validation, Continued Process Verification, etc.)
Demonstrated leadership in providing integration of activities and information across multifunctional groups and matrix teams. Organizing, coordinating teams, and setting up and maintaining communication with stakeholders and wider network organization.
Project management skills; capable of effective integration of deliverables and support execution at the manufacturing site level.
Motivated, self-starter able to work independently with demonstrated problem-solving skills.
Good knowledge of Quality and Compliance, and regulatory requirements.

Other:

Fluent in written and spoken English
10-25% travel may be required, depending on project needs

Description

Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing novel, integrated drug and delivery solutions for the localized treatment of patients with chronic rhinosinusitis (CRS) and other chronic diseases. Lyra has two investigational product candidates, LYR-210 and LYR-220, in late-stage development for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities. LYR-210 and LYR-220 are bioresorbable polymeric matrices designed to be administered in a brief, non-invasive, in-office procedure and are intended to deliver up to six months of continuous mometasone furoate drug therapy to the sinonasal passages as an alternative to sinus surgery. LYR-210 is designed for surgically naïve patients and is being evaluated in the ENLIGHTEN Phase 3 clinical program, while LYR-220, an enlarged matrix, is being evaluated in patients who have recurrent symptoms despite surgery in the BEACON Phase 2 clinical trial. These two product candidates are designed to treat the estimated four million CRS patients in the United States who fail medical management each year.

Our team is growing, and we are currently recruiting MSAT Engineering Manager to join our dynamic team. This role represents a unique opportunity to leverage past experience and skills to launch our LYR-210 product from Waltham, our cutting-edge commercial GMP manufacturing facility, and support continued clinical production of LYR-220.

The MSAT Engineering Manager will lead a team responsible for drug products from new product launch through commercial and clinical production at Waltham and/or Watertown, MA sites. Responsibilities of this role shall include both hands-on tactical support of ongoing plant operations and strategic implementation engineering projects to meet the changing needs of the business. This involves the startup of a new commercial manufacturing site, technology transfer, and process validation. The Process Engineering Manager will report to the Director of Manufacturing Science and Technology (MSAT).

Responsibilities

Work with cross-functional teams to drive execution of key launch/tech transfer deliverables and produce required documentation (VMP, PPQ protocol, PPQ report, etc.)
Lead collaborations with commercial manufacturing and quality to support ongoing qualification activities associated with maintaining a commercial product (new material qualifications, new equipment qualifications, etc.)
Be an owner of commercial and clinical product(s) and be accountable for engineering-related Change Controls, Deviations, CAPAs, and Continuous Improvements
Resolve complex commercial manufacturing issues and provide technical support of critical process-related deviations in terms of leading root cause investigations and implementation of corrective or preventative actions
Oversee process trending of CPPs and develop/implement CPV solutions for manufacturing. Monitor CQAs and develop/implement SPC solutions for manufacturing
Supporting continuous validation / verification of the site Master Validation Plan and inventory of site validations
Support site validation related activities for the design, commissioning, qualification, and continued validation maintenance of all equipment, facilities, and utilities, including identification of opportunities for improvement
Drive continuous improvement activities and operational excellence, including reduction of Cost of Goods Sold (COGS) and commercial readiness
Build and lead a team of process engineering experts who will work closely together and within a highly matrixed, cross-functional team to successfully deliver business objectives
Provide input and act as key stakeholder for design review, equipment specifications, performance criteria, success factors, budget management, and construction & installation oversight for specified capital projects

Requirements

Bachelor’s Degree (Engineering Preferred) with 10+ years of experience. Master’s Degree (Engineering Preferred) with 8+ years of experience
Prior experience in developing and/or managing engineers
Experience with equipment design, commissioning, troubleshooting, etc for cGMP environment
Understanding of engineering principles for manufacturing combination device/drug product, and/or pharma batch processes, and/or medical device Class III, spray coating mechanics, oven drying, and packaging
Fundamental understanding and application of technology transfer and validation processes
Prior experience in authoring & executing process validation studies for commercial GMP manufacturing processes including process qualification (IOQ, PPQ, RQ) and managing validation teams
Strong communication (written and verbal), collaboration, and team building skills; ability to connect with all levels of the organization
Working knowledge of risk assessment methodologies and practices including prior experience using risk analysis for testing strategy development and justification

At Lyra, we value creativity, leadership, and collaboration. The company sees significant expansion opportunities for our platform, and look for people who are driven to succeed, innovative, and adaptable. For consideration, please submit cover letter and CV.

Please visit www.lyratx.com for more information.

","hiringOrganization":{"@type":"Organization","name":"Lyra Therapeutics","sameAs":"https://lyratherapeutics.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Watertown, MA, US","addressCountry":"United States","addressRegion":"North America"}}}},{"@type":"ListItem","position":12,"item":{"@type":"JobPosting","title":"Lead MSAT- FTO","datePosted":"2025-08-11","description":"

Company Description

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

Job Description

Job Summary
\nWe are seeking a candidate to ensure robustness in all manufactured products by overseeing process engineering, incident closure, and effective CAPA implementation. Responsibilities include reviewing equipment qualification, collaborating on risk assessments, and initiating improvements for safety and efficiency. The role involves leading Management of Change (MOC) processes, fostering cross-learning within the Process Engineering community, and developing common solutions for platform issues.
\n
\nRoles & Responsibilities
\n• You will be responsible for ensuring the continual process robustness in all manufactured products at the site by incorporating expectations and actions in the process engineering team's LDM (Learning Development Matrix).
\n• Your role includes overseeing the closure of incidents and investigations with effective CAPA, addressing root causes to prevent repeat incidents.
\n• Your role involves reviewing the qualification of equipment and cleaning procedures to ensure robustness and documenting learnings to create an organizational knowledge repository.
\n• Additionally, you will collaborate with cross-functional teams to conduct risk assessments for all production processes, considering process, personnel, and environmental safety.
\n• You will recommend and support improvements, including actions such as P&ID (piping and instrumentation diagram and URS (User Requirement Specification) preparation, procedure development, and addressing safety risks.
\n• You will initiate Management of Change (MOC) and Pre-Startup Safety Review (PSSR) processes to ensure the fulfillment of recommended changes and enhance process safety.
\n• You will be responsible for continuous improvements in quality, removal of bottlenecks in production capacity, batch cycle times, yield improvements beyond budgets, technologies, and waste reduction.
\n• You will be responsible for fostering cross-learning within the Process Engineering community under the MSAT (Manufacturing Science and Technology) umbrella. This involves actively participating in and driving opportunities for knowledge exchange that arise from being part of a larger fraternity.
\n• Your role includes learning from experiences at other sites and sharing insights gained from associated sites.
\n• You will be responsible for developing common solutions for platform issues impacting multiple sites and creating best practices for the FTOs (Formulation Technology Organization--- Injectables).
\n• Your role involves assessing opportunities and implementing changes related to scale-up and modifications in processes/equipment at various stages of product development.
\n• You will interact with cross-functional teams (CFT) and prepare risk assessments for any modifications or changes.

Qualifications

Educational qualification: A Bachelor's degree in Chemical Engineering/B. Pharm/ M. Pharm or a related field; advanced degree (Master's or PhD) preferred
\n
\nMinimum work experience: Approx 15-20 years of experience in Process Engineering, with a focus on continuous process improvement, robustness, and safety in pharmaceutical manufacturing ( Primarily in Injectable)
\n
\nSkills & attributes:
\nTechnical Skills
\n• Strong knowledge on CIP/SIP and other SKID process application

* Knowledge of working on complex Equipment ( High Pressure Homogenizer, Aseptic ANFD, SKID process Mfg processes, Microfluidizer, Homogenizer, Bead mill in aseptic methodology

* Knowledge on Sterile Filtration, Filling, Lyo

* Knowledge on Media fill strategy finalization.

* Capable to Review and/or prepare PID/FS/FDS etc

*Extensive knowledge of continual process robustness, equipment Installation & qualifications, cleaning procedures, and safety risks.
\n• Proven ability to oversee the closure of incidents and investigations with effective CAPA and addressing root causes to prevent repeat incidents.
\n• Strong focus on continuous improvements in quality, production capacity, batch cycle times, yield improvements, technologies, and waste reduction.
\n• Ability to develop common solutions for platform issues impacting multiple sites and preparing risk assessments for any modifications or changes.
\n• Proven experience in assessing opportunities and implementing changes related to scale-up and modifications in processes/equipment at various stages of product development.

*Behavioural skills
\n• Strong leadership skills to drive opportunities for knowledge exchange and implement changes for continuous improvement.
\n• Effective collaboration with cross-functional teams, fostering a culture of continuous learning and improvement.
\n• Analytical mind set for assessing risks, recommending improvements, and implementing changes in processes.
\n• Excellent communication skills for sharing insights, preparing risk assessments, and collaborating with diverse teams.

Additional Information

About the Department

Integrated Product Development Organisation

We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages
\nOur product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.

\nBenefits Offered
\nAt Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
\nThe benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.
\n
\nOur Work Culture
\nAsk any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
\nFor more details, please visit our career website at https://careers.drreddys.com/#!/

Purpose

Work in a global team of statistical experts to provide statistical support to Global Supply Chain sites and functions.
Focus on the delivery of statistical analysis required to support new product introduction (e.g. regulatory submissions, validation activities) and established products (e.g. root cause analysis investigations, batch quality assessments) aligned to the requirements of Product Lifecycle Management.
Act as an essential and accountable partner of cross-functional global teams (including investigations, task forces, improvement projects), management and key stakeholders in the organisation to provide statistical input to assessments and guide appropriate interpretation.
As a Subject Matter Expert in Statistics, help build the statistical capability of GSC across all sites and functions

Responsibilities

Support cross-functional global teams by providing statistical expertise to help interpret statistical outputs and use these alongside other scientific understanding to drive outcomes aligned to GSK values. This especially includes contribution to the resolution of deviations and improvement projects.
Carry out statistical analysis, report and communicate results and conclusions in the form of technical documents and presentations in accordance with regulatory and internal guidance. Take ownership and accountability of statistical content. Typical applications include study design and sample size calculation, process and method validation, assay or process trending, assay or process transfers.
Ensure compliance of data analyses with internal and external requirements (e.g. GSK QMS, GSK SOPS, Ph.Eur., ICH/FDA guideline).
Ensure integrity of statistical evaluation by ensuring application of appropriate statistical methodologies and traceability / reproducibility.
Contribute to local and global documents with statistical content, e.g. SOPs, guidelines.
Contribute to development and standardisation of data evaluation methodologies and conventions. This especially includes active participation with the wider statistics network (MSAT, Quality, TRD and R&D, as well as with the GPS community) to help ensure that best practises are incorporated into local ways of working.
Assist with upskilling ofl the organisation through coaching, mentoring and training of nonstatisticians and junior statisticians as required on the appropriate application of statistics and data evaluation tools for their business processes.

Knowledge, Skills & Experience

Master’s degree in Statistics, Data Science, Mathematics, or a related field.
At least 2 years of relevant experience in applying statistics, preferably in a pharmaceutical or manufacturing environment.
Proficiency in statistical software (e.g., SAS, R, JMP, Python).
Strong communication skills and ability to work collaboratively in cross-functional teams.

Preferred Qualifications:

PhD in Statistics or related field.
Experience with Quality by Design (QbD) principles.
Familiarity with biopharmaceutical processes or vaccines industry.
Experience in global teams and interdisciplinary environments.

To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore 

#Li-GSK 

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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Are you energized by a highly technical packaging design role that allows you to enhance your leadership skills in a state-of-the-art manufacturing environment? If so, this Associate Director MSAT Packaging role could be an exciting opportunity to explore.

As an Associate Director MSAT Packaging, you will manage an MSAT packaging team which is responsible for the development and implementation of sterile primary packaging standards to be applied globally, development and qualification of all primary packaging from phase III to commercial, life-cycle management of the already qualified primary packaging.

The Associate Director, Packaging Operations, MSAT Drug Delivery & Aseptic Technology - is responsible to lead a team of packaging experts that are responsible for leading large primary packaging package development projects which impact multiple sites. This will include initiatives

from a variety of areas including NPI, packaging standard platforms, cost reduction. compliance, supply risk, and sustainability.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Management activities for the team including but not limited to:

• Establishing goals and objectives

• Performance management

• Salary Administration

• Development Plans

• Training compliance

• Recruiting

Oversee the packaging development and qualification activities to assure they are completed in accordance with QMS requirements and regulatory expectations.

Provide guidance on prioritization based on the impact of the project on the business.
Engage a range of stakeholders to gain insight and provide input into packaging platform strategy.
Monitor and support the team to achieve KPI’s related to Quality (deviations, Capa’s, training, document review/approval, etc.)
Participate in project governance structure to seek endorsement of proposals at the level appropriate for the scope of the initiative.
Technical Leadership of primary packaging to support the team with issue resolution within the supply chain across multiple sites globally to ensure security of supply.
Development of strong relationships with key stakeholders across the business (including procurement, quality, regulatory, and supply chain) to ensure appropriate engagement and input into qualification plans.
Provide technical input to the team to ensure appropriate risk-based decision making
Provide technical packaging input to drive resolution plans and appropriate escalation

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

Bachelor’s degree in engineering or related Science field
5+ years of experience in packaging development
Previous experience managing a technical team.
Experience with consumer driven insights and translating into packaging innovations

The selected candidate will be hired at the appropriate level based on experience

Associate Director (grade 6): 5+ years of experience in pharmaceutical primary packaging development/qualification and 3+ years of experience managing a technical team.
Manager (grade 6): 5+ years of experience in pharmaceutical primary packaging development/qualification and demonstrated leadership of cross functional project teams.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

Master’s degree in engineering or related Science Field
Must have extensive experience in the sterile primary packaging field including container closure qualification and implementation.
Awareness of current regulatory expectations related to sterile primary packaging qualification
Proven track record for managing a virtual matrix team within a complex, multi-disciplinary technical organization, and working across organizational, territorial, and cultural boundaries.
Knowledge/Expertise of packaging materials, components, suppliers, equipment, legislation, and technologies with the ability to apply this knowledge to satisfy goals within Supply Chain.
Ability to react quickly and positively to rapidly changing environments and newly emerging information.
Demonstrated ability to manage and control multiple tasks simultaneously.
Understanding of the complexities of multi-site manufacture for GSK Products, internal and within External Supply
Superior listening skills, analytical ability to diagnose problems, resolve conflict, and develop practical solutions.
Excellent communication skills, both interpersonal and presentation; able to interact with and influence all levels of individuals across a variety of organizations (without a direct reporting relationship).
Provide a professional service that understands urgency, rapid response and follow-up.
Must be able to work in a matrix environment both within the Supply Chain and across R&D, and Commercial where applicable.
Individual must be able to exhort influence with peers across Divisions as well as up and down within GSK organizations in order to obtain desired outcomes.
Build confidence across all stakeholders in own ability to identify, evaluate and make change happen.
Understanding different perspectives and satisfying the needs and expectations of all stakeholders.
Build peer networks and manage relationships with our supplier base and be able to diagnosis and resolve problems that occur in the GSK network.
Develop strong relationships with Procurement groups and suppliers of packaging components

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Important notice to Employment businesses/ Agencies

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

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Principal MSAT Scientist

Location: Edinburgh BioQuarter

Who are we?

We are RoslinCT, a world-leading Cell and Gene Therapy Contract Development and Manufacturing Organisation creating cutting-edge therapies that change people’s lives.

Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.

Find out more about what we do here!

Why join us?

The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career.
A generous salary package - we reward our people at the level they deserve.
Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us.
31 days of annual leave, plus 4 public holidays which increases with tenure.
A competitive company pension scheme to help you save for the future.
Group Life Cover – you are automatically covered for three times your basic salary to give you and your family peace of mind.
Flexible benefits such as retail discounts and access to the Cycle2Work scheme.

Your new role

The Principal Manufacturing Science and Technology (MSAT) Scientist will be responsible for providing in-depth technical leadership and guidance on the commercial manufacturing of CASGEVY® by managing complex changes associated with scale-out, life cycle management, right first time and efficient operations with directly reporting to MSAT Manager.

You will have direct contact with RoslinCT’s client, supporting with long-term process improvements and quality investigations.
Create realistic, innovative solutions to complex technical and operational challenges, analysing data and presenting recommendations to both senior and executive management.
Continuously drive process improvements to embed a right first-time culture, ensuring best practices, efficient methodologies, and consistent quality standards are maintained.
Support the resource allocation and timeline planning of new projects or demand.
Lead, manage, and develop a team of MSAT Scientists and Associate MSAT Scientists, providing mentorship, technical guidance, and performance feedback to build capability and expertise within the team.
Work closely with, and facilitate technical support, to wider departments within the business.
Collaborate with the Business Development team on client engagement and development of new sales proposals.
Ensure that all technical transfer activities are conducted in compliance with GMP, health and safety, and other relevant regulatory standard.

About you

Prior team leadership experience in a GMP manufacturing environment, preferably within Commercial sterile manufacturing.
Working knowledge of cGMP systems and FDA/EU regulations within cell and gene therapy manufacturing.
Experience working with stem cells, cellular therapies or cell banking.
Exceptional communication skills - working closely with individuals at all levels including RoslinCT employees, stakeholders and suppliers.
A desire to support continuous improvement, with a right first-time approach.
Ability to work under pressure to meet client demands and deadlines.
Due to business-critical needs, this role will require flexibility on working hours when required.

Qualifications

A Degree in Life Sciences, or related subject.

Next Steps

If this sounds like you, then please hit ‘Apply’ now. We will ask you to upload your CV and complete a short application form detailing why you are interested and why we should hire you.

At RoslinCT, we’re all about inclusivity and creating a fair, welcoming workplace. Our goal is to make sure everyone knows they’re valued and encouraged to be themselves, whether they’re our employees, customers, or partners.

We take pride in being an equal opportunity employer. We treat all applicants fairly and don’t discriminate based on any protected characteristics. So, no matter who you are, we welcome your application with open arms.

If you’ve got any specific needs or concerns regarding accessibility during the recruitment process, don’t hesitate to reach out to us at jobs@roslinct.com. We’re here to assist and make things as smooth as possible for you.

","hiringOrganization":{"@type":"Organization","name":"RoslinCT","sameAs":"https://www.roslinct.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Edinburgh, United Kingdom","addressCountry":"United Kingdom","addressRegion":"Europe"}}}},{"@type":"ListItem","position":16,"item":{"@type":"JobPosting","title":"Assoc Specialist - MSAT","datePosted":"2025-08-13","description":"

Basic Qualifications:

Advanced degree in chemistry, biology, chemical engineering or similar field of study.
Knowledge of sterile drug product primary pack & devices, qualification process
Project management skills and validation technical skills
Experience with at least 2–6 year primary pack & devices qualification for a Pharmaceutical or Biopharmaceutical company.
Ability to resolve complex technical issues by bringing creative solutions with the right quality framework
Knowledge and understanding of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and ISO standards.
Hands on mentality/approach and ability to work in the laboratory.
Flexibility to face rapidly changing environment
Ability to work in a matrix international organization.
Proficiency in writing DSR, FMEA, URS, DQ, VMP, IOQ, VSR, qualification protocol, extractable protocols, biocompatibility reports, and leachable risk assessments and PES calculation.
Written and oral fluency in English.
Excellent communication and negotiation skills.

Preferred Qualifications:

Competent in use of templates and forms
Strong skills in Microsoft Excel, Microsoft Office, and PowerPoint
Good understanding of good manufacturing practices
Ability to understand technical processes
Excellent communication skills
Ability to train and coach others

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

Important notice to Employment businesses/ Agencies

It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.

GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.

If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.

","hiringOrganization":{"@type":"Organization","name":"GSK","sameAs":"https://www.gsk.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bengaluru Luxor North Tower, India","addressCountry":"India","addressRegion":"Asia/Pacific"}}}},{"@type":"ListItem","position":17,"item":{"@type":"JobPosting","title":"Associate/Director, MSAT","datePosted":"2025-08-17","description":"

Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio!

AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.

The AmplifyBio ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA)– Amplify's Discovery, Optimization, and Characterization laboratories: ASET (West Jefferson, OH) – Amplify's Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) – Amplify's Manufacturing Enablement Center.

About AMEC New Albany, OH: AmplifyBio’s Manufacturing Enablement Center provides customizable cGMP suites to enable advanced therapy manufacturing in a “hoteling model,” traditional contract development and manufacturing (CDMO) or a hybrid model. Partnering with AmplifyBio for manufacturing cell therapy, gene therapy, mRNA, plasmid, or other modality is quite different from a typical CDMO experience. The goal is to provide flexible solutions customized to client needs while bringing full expert partnership. At AmplifyBio drug developers will find an innovation-rich ecosystem designed to advance a diverse range and class of pharmaceutical products across development stages.

AmplifyBio is seeking to hire an Associate/Director of MSAT to join our growing team!!!

The Associate/Director, MSAT you will lead a team responsible for transferring, developing, and optimizing manufacturing processes into AmplifyBio’s Manufacturing Enablement Center (AMEC) Facility. You will play a critical role in ensuring the robustness, scalability, and compliance of manufacturing processes to support the successful development and commercialization of cell and gene therapy products. This position is hands-on, and requires strong leadership, technical expertise, and a deep understanding of regulatory requirements.

The Associate/Director, MSAT will play a critical role in ensuring the quality, compliance, and efficiency of manufacturing operations within a cutting-edge field of biotechnology!

What You’ll Do Here:

Manufacturing Execution:
- Lead the tech transfer, development, and optimization of manufacturing processes for advanced therapies, including cell culture, gene editing, downstream processing, fill/finish operations.
- Establish SOPs, batch records, and work instructions for the production of cell and gene therapy products.
- Ensure the manufacturing team successfully executes tasks related to drug substance and drug product processing, including cell expansion, transfection, purification, formulation, and fill/finish operation.
Technology Transfer and Scale-Up:
- Lead the transfer of manufacturing processes from client organizations to internal clinical and commercial manufacturing sites.
- Perform facility fit and generate the necessary documentation for process control strategy (IPCs, PFDs, Process Descriptions) to transition processes from pre-clinical to clinical / commercial GMP manufacturing, ensuring scalability, efficiency, and cost-effectiveness.
- Prepare and operate equipment, such as bioreactors, centrifuges, chromatography systems, and filtration units, following safety and operational protocols.
Quality Assurance and Compliance:
- Ensure compliance with regulatory standards (e.g., FDA, EMA, ICH) and industry best practices for cell and gene therapy manufacturing.
- Drive authorship of protocols and reports to enable manufacturing compliance (APS, EMPQ, etc.).
- Oversee investigations into deviations, implement corrective actions, and ensure documentation of manufacturing activities to maintain product quality and regulatory compliance.
Cross-functional Collaboration:
- Collaborate with cross-functional teams, including client organizations, Quality Assurance, Quality Control, and Supply Chain, to support the tech transfer of cell and gene therapies.
- Ensure alignment of manufacturing activities with project timelines and regulatory requirements.
Process Validation and Regulatory Submissions:
- Lead process validation activities, including protocol development, execution, and documentation, to demonstrate the robustness and compliance of manufacturing processes.
- Provide expertise and guidance on regulatory strategy for cell and gene therapy manufacturing, including preparation of regulatory submissions and participation in regulatory inspections.
Continuous Improvement:
- Drive continuous improvement initiatives to optimize manufacturing processes, reduce costs, and increase efficiency while maintaining product quality and compliance with regulatory requirements.
- Implement best practices and lessons learned from process development and manufacturing experience.
Leadership and Team Management:
- Provide leadership, mentorship, and guidance to a team of scientists, engineers, and technical professionals within the MSAT organization.
- Foster a culture of innovation, collaboration, and continuous learning to support the growth and development of the team.

We Would Love to Hear from You If:

Bachelor's degree in biological sciences, bioengineering, or related field (advanced degree preferred).
Minimum of 10 years of experience in cell and gene therapy manufacturing or related biopharmaceutical industry.
Demonstrated leadership experience in leading cross-functional teams and managing complex projects.
Strong understanding of regulatory requirements and guidelines for cell and gene therapy manufacturing (e.g., cGMP, FDA regulations).
Excellent communication, problem-solving, and decision-making skills.
Proven track record of driving process optimization, technology transfer, and continuous improvement initiatives.

Preferred Qualifications:

Experience with cell and gene therapy tech transfer, scale-up, validation, and commercialization.
Prior experience in a leadership role within MSAT or process development function.
Knowledge of advanced manufacturing technologies and platforms for cell and gene therapy production.
Experience with regulatory submissions and interactions with regulatory agencies.

At AmplifyBio, we're committed to growing and empowering an inclusive community within our company and industry. Therefore, we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization.

AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.

Why You Will Love Working Here:

We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program to financial planning and legal assistance, we make sure to take care of our own.

Health, Dental, and Vision insurance that starts on your first day at AmplifyBio!
Competitive Compensation Package
We take work-life balance seriously and we back it up with a UNLIMITED PTO policy.
Generous paid parental leave
Wellness and Self-Care Programs
401(k) match
Tuition Reimbursement
EAP/work-life support system
A fun work environment where everyone’s voice matters.
We are just getting started! More benefits on the way!
An Opportunity to Change the World!!!

When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians, and specialists across a variety of disciplines. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.

","hiringOrganization":{"@type":"Organization","name":"AmplifyBio","sameAs":"https://www.amplify-bio.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"New Albany, OH, US","addressCountry":"United States","addressRegion":"North America"}}}},{"@type":"ListItem","position":18,"item":{"@type":"JobPosting","title":"Lead MSAT- FTO","datePosted":"2025-08-20","description":"

Company Description

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

Job Description

Qualifications

* Knowledge of working on complex Equipment ( High Pressure Homogenizer, Aseptic ANFD, SKID process Mfg processes, Microfluidizer, Homogenizer, Bead mill in aseptic methodology

* Knowledge on Sterile Filtration, Filling, Lyo

* Knowledge on Media fill strategy finalization.

* Capable to Review and/or prepare PID/FS/FDS etc

Additional Information

About the Department

Integrated Product Development Organisation

Purpose

Work in a global team of statistical experts to provide statistical support to Global Supply Chain sites and functions.
Focus on the delivery of statistical analysis required to support new product introduction (e.g. regulatory submissions, validation activities) and established products (e.g. root cause analysis investigations, batch quality assessments) aligned to the requirements of Product Lifecycle Management.
Act as an essential and accountable partner of cross-functional global teams (including investigations, task forces, improvement projects), management and key stakeholders in the organisation to provide statistical input to assessments and guide appropriate interpretation.
As a Subject Matter Expert in Statistics, help build the statistical capability of GSC across all sites and functions

Responsibilities

Support cross-functional global teams by providing statistical expertise to help interpret statistical outputs and use these alongside other scientific understanding to drive outcomes aligned to GSK values. This especially includes contribution to the resolution of deviations and improvement projects.
Carry out statistical analysis, report and communicate results and conclusions in the form of technical documents and presentations in accordance with regulatory and internal guidance. Take ownership and accountability of statistical content. Typical applications include study design and sample size calculation, process and method validation, assay or process trending, assay or process transfers.
Ensure compliance of data analyses with internal and external requirements (e.g. GSK QMS, GSK SOPS, Ph.Eur., ICH/FDA guideline).
Ensure integrity of statistical evaluation by ensuring application of appropriate statistical methodologies and traceability / reproducibility.
Contribute to local and global documents with statistical content, e.g. SOPs, guidelines.
Contribute to development and standardisation of data evaluation methodologies and conventions. This especially includes active participation with the wider statistics network (MSAT, Quality, TRD and R&D, as well as with the GPS community) to help ensure that best practises are incorporated into local ways of working.
Assist with upskilling ofl the organisation through coaching, mentoring and training of nonstatisticians and junior statisticians as required on the appropriate application of statistics and data evaluation tools for their business processes.

Knowledge, Skills & Experience

Master’s degree in Statistics, Data Science, Mathematics, or a related field.
At least 2 years of relevant experience in applying statistics, preferably in a pharmaceutical or manufacturing environment.
Proficiency in statistical software (e.g., SAS, R, JMP, Python).
Strong communication skills and ability to work collaboratively in cross-functional teams.

Preferred Qualifications:

PhD in Statistics or related field.
Experience with Quality by Design (QbD) principles.
Familiarity with biopharmaceutical processes or vaccines industry.
Experience in global teams and interdisciplinary environments.

To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore 

#Li-GSK 

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Important notice to Employment businesses/ Agencies

","hiringOrganization":{"@type":"Organization","name":"GSK","sameAs":"https://www.gsk.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Jurong, Singapore","addressCountry":"Singapore","addressRegion":"Asia/Pacific"}}}},{"@type":"ListItem","position":20,"item":{"@type":"JobPosting","title":"MSAT SM Trainee","datePosted":"2025-08-21","description":"

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

Join Johnson & Johnson as Process and Cleaning Validation Solids Trainee.

This outstanding opportunity is open to final-year students or fresh graduates interested in working in the field of Synthetics Drug Susbtance supply chain. In this position, trainees will have the chance to learn various aspects of manufacturing and cleaning processes for the preparation of drug substance destinated to human use and corresponding product lifecycle management, including the basis of GMP (Good Manufacturing Practice) and some regulatory requirements. Together with this knowledge the candidate will learn to work in a dynamic working environment, supporting the MSAT Synthestics team and interacting with multidisciplinary and multicultural teams.

Responsibilities for this role will include:

· Deep learning in Synthetics API manufacturing in an GMP environment

· Knowledge and gaining experience in High-Potent API manufacturing

· Providing administrative and logistic support to MSAT Synthetics API local team in organizing meetings business related and other relevant tasks.

· Providing support for document writing and approval.

· Responsible for periodic review and updating of relevant documents.

· Collecting and classifying data for the creation of a local MSAT knowledge database center.

· Learning and apply the basis of GMP roles, product life cycle management and cleaning/manufacturing fundamental processes for Solids formulation.

What we offer in this trainee program is:

· Full-time employment contract for two years.

· Broad experience in product life cycle management, manufacturing and cleaning processes for Synthetics API by having access to manufacturing area and working with experienced process engineers.

Requirements: We are seeking fresh university graduates or students in their final year of university. Bachelor's or University degree in Life Science, Chemistry, or Engineering. Proficiency in using Microsoft Word, Excel, and PowerPoint. Advanced English language skills. Excellent organizational and problem-solving abilities. Strong interpersonal skills. Ability to perform tasks accurately and in a timely manner.

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Latina, Italy

Job Description:

- As Project Leader ensure planning and coordination of the activities in collaboration with the various departments involved in the implementation of the projects

- Proactively identifying risks to define mitigation strategies

- Assess the business impact, quality, compliance and safety involving stakeholders from other departments

- Ensure compliance with the time of introduction, balancing the base business production needs

- Ensure timely communication to MSAT Sr Mgr and Global Functions to align with the production plans themselves

- Ensure the timely availability of quality documentation for the project execution

- Performs and/or support investigations for non-conformances in case of occurrence during project activities

- Process Analytical Technologies, Multivariate Analysis & chemometrics application

Requirements

· Master’s degree in Engineering, Farmacy, CTF or Chemistry

· At least 6th month experience in the pharmaceutical industry (Oral Solid production is preferred)

· Academic knowledge of lines, processes, materials and equipment for pharmaceutical process (oral solid pharma production competence is preferred).

· Good knowledge of quality, compliance and GMP related to manufacturing and packaging of pharmaceutical products

· Basic experience in Project Management

· Able to work in a multidepartment and dynamic environment and to deal urgencies on the shop floor

· Ability to coordinate a cross functional team to ensure the correct execution of the project activities according to the agreed timing

· Skills of ownership and accountability

· Skilled in problem-solving and decision making

· Knowledge and basic experience in PAT, MVA and Chemometrics applications.

· Fluent in English (B2 level and above)

· Capacity to lead calls with costumers

· Capability to easily connect with people and prepare smart proposals for project approaches

· Excellent oral and written communication skills

· Ability to present scientific data and concepts effectively to international standards

","hiringOrganization":{"@type":"Organization","name":"Johnson & Johnson","sameAs":"https://www.jnj.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"IT003 Borgo San Michele(Latina), Italy","addressCountry":"Italy","addressRegion":"Europe"}}}},{"@type":"ListItem","position":22,"item":{"@type":"JobPosting","title":"Principal MSAT Engineer","datePosted":"2025-08-29","description":"Kyverna is seeking a highly motivated Principal MSAT Engineer. This position will play a pivotal role in supporting/leading Technology Transfer (TT) activities, including training internal and external manufacturing and MSAT teams. This role will also drive process improvements for our lead assets, with support from PD. The ideal candidate will contribute to our goals of navigating what’s next in synthetic biology, immunology and cell engineering while living our core values: Bring Intellectual Rigor, Elevate Each Other, and Stay True To Why.
Title: Principal MSAT EngineerReporting to: Director MSATWork Location: Emeryville, CA (Hybrid twice a week)\n

Responsibilities

Lead all aspects of Technology Transfer (TT), including training internal and external manufacturing and MSAT teams.
Drive process optimization and continuous improvement initiatives for lead assets in collaboration with Process Development (PD).
Serve as the MSAT Lead supporting CDMO facilities for Asset 1.
Provide expertise in process validation, process performance qualification (PPQ), and commercial product launch readiness.
Prepare, present, and communicate technical findings, progress, and recommendations to leadership and cross-functional teams.
Lead or support product impact assessments, deviation investigations, trending analyses, CAPAs, and change controls.
Monitor, interpret, and analyze manufacturing data to identify trends, drive process improvements, and resolve technical issues.
Contribute to risk assessments, including process FMEAs, to inform validation strategies and new product introductions at CDMOs.
Lead systematic, data-driven investigations using DMAIC methodology to determine root cause and implement corrective measures, including knowledge of critical equipment.
Participate in the evaluation, adoption, and implementation of new technologies and process automation.
Author or support regulatory submissions and provide audit readiness and on-site audit support (internal and CDMO).
Identify, assess, and communicate risks associated with processes, technologies, and methods, recommending mitigation strategies.

Qualifications

Bachelor’s degree in Engineering, Pharmaceutical Sciences, or related field; advanced degree preferred.
8+ years of biotech/pharma experience, ideally in cGMP manufacturing or manufacturing support.
Strong knowledge of cGMP regulations, quality systems, and compliance requirements.
Expertise in biologics manufacturing, aseptic processing, cell therapy, and process development.
Experience with process validation, PPQ, and late-stage/commercial manufacturing.
Proficiency with statistical tools (e.g., JMP, Minitab) and data management systems.
Familiarity with Lean Six Sigma principles; certification a plus.
Excellent problem-solving, communication, and collaboration skills.
Adaptable, self-motivated, and able to work independently in a fast-paced environment.

The salary range for this position is from $160,000 to $190,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.","hiringOrganization":{"@type":"Organization","name":"Kyverna","sameAs":"https://kyvernatx.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Emeryville, CA","addressCountry":"United States","addressRegion":"North America"}}}},{"@type":"ListItem","position":23,"item":{"@type":"JobPosting","title":"Principal MSAT Scientist","datePosted":"2025-09-02","description":"

Principal MSAT Scientist

Location: Edinburgh BioQuarter

Who are we?

We are RoslinCT, a world-leading Cell and Gene Therapy Contract Development and Manufacturing Organisation creating cutting-edge therapies that change people’s lives.

Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.

Find out more about what we do here!

Why join us?

The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career.
A generous salary package - we reward our people at the level they deserve.
Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us.
31 days of annual leave, plus 4 public holidays which increases with tenure.
A competitive company pension scheme to help you save for the future.
Group Life Cover – you are automatically covered for three times your basic salary to give you and your family peace of mind.
Flexible benefits such as retail discounts and access to the Cycle2Work scheme.

Your new role

You will have direct contact with RoslinCT’s client, supporting with long-term process improvements and quality investigations.
Create realistic, innovative solutions to complex technical and operational challenges, analysing data and presenting recommendations to both senior and executive management.
Continuously drive process improvements to embed a right first-time culture, ensuring best practices, efficient methodologies, and consistent quality standards are maintained.
Support the resource allocation and timeline planning of new projects or demand.
Lead, manage, and develop a team of MSAT Scientists and Associate MSAT Scientists, providing mentorship, technical guidance, and performance feedback to build capability and expertise within the team.
Work closely with, and facilitate technical support, to wider departments within the business.
Collaborate with the Business Development team on client engagement and development of new sales proposals.
Ensure that all technical transfer activities are conducted in compliance with GMP, health and safety, and other relevant regulatory standard.

About you

Prior team leadership experience in a GMP manufacturing environment, preferably within Commercial sterile manufacturing.
Working knowledge of cGMP systems and FDA/EU regulations within cell and gene therapy manufacturing.
Experience working with stem cells, cellular therapies or cell banking.
Exceptional communication skills - working closely with individuals at all levels including RoslinCT employees, stakeholders and suppliers.
A desire to support continuous improvement, with a right first-time approach.
Ability to work under pressure to meet client demands and deadlines.
Due to business-critical needs, this role will require flexibility on working hours when required.

Qualifications

A Degree in Life Sciences, or related subject.

Next Steps

If this sounds like you, then please hit ‘Apply’ now. We will ask you to upload your CV and complete a short application form detailing why you are interested and why we should hire you.

","hiringOrganization":{"@type":"Organization","name":"RoslinCT","sameAs":"https://www.roslinct.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Edinburgh, United Kingdom","addressCountry":"United Kingdom","addressRegion":"Europe"}}}},{"@type":"ListItem","position":24,"item":{"@type":"JobPosting","title":"Lead MSAT- FTO","datePosted":"2025-09-02","description":"

Company Description

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

Job Description

Qualifications

* Knowledge of working on complex Equipment ( High Pressure Homogenizer, Aseptic ANFD, SKID process Mfg processes, Microfluidizer, Homogenizer, Bead mill in aseptic methodology

* Knowledge on Sterile Filtration, Filling, Lyo

* Knowledge on Media fill strategy finalization.

* Capable to Review and/or prepare PID/FS/FDS etc

Additional Information

About the Department

Integrated Product Development Organisation

MSAT Technical Writer

We’re looking for a colleague to take ownership of cGMP Documentation within Legend Biotech, together with the team you ensure documentation is updated and in alignment with the needs of the business. Do you have a solid understanding of GMP guidelines and biotech / pharma processes, with the interest in building up expertise in tech writing? Apply on the role and let’s discuss the details!

What can you expect?

Technical Writing: Master batch records are key documents in manufacturing. They outline the instructions, procedures, and requirements for producing drug products that meet regulatory and quality standards. As a technical writer, you make sure these and other process documents are kept up to date.
SPOC: As SPOC for batch records, you’re responsible for both the paper and electronic batch records. You stay in touch with the team that manages the electronic batch records and align with colleagues what needs to happen and how it will be implemented in the documentation.
In general, this is an administrative role in which you can use scientific insights / knowledge to ensure compliance with GMP.

Who are we looking for?

Must have:

A Bachelor’s degree in a relevant field such as Biotechnology, Chemistry, or a similar discipline.

A first work experience is highly appreciated if relevant. With the right studies we are open to discuss the role.

Fluent in English, with the ability to collaborate effectively across teams and functions.

Nice to have:

Dutch knowledge is a nice to have.

MES knowledge is a nice to have.

CAR-T process knowledge is a nice to have.

What do we offer you?

A meaningful job with an excellent work-life balance. You work in day hours, with the opportunity to work from home two days a week.

A supportive and innovative work environment. We value and encourage learning and personal development.

The opportunity to work with people from all over the world.

A contract of indefinite duration and an attractive salary package complemented by many fringe benefits, such as additional statutory vacations, meal vouchers, group and hospitalization insurance, double vacation pay, an end-of-year and performance bonus.

Many fun and informal events.

About Legend Biotech

Legend Biotech is a global biotechnology company dedicated to developing, manufacturing, and commercializing innovative and life-saving cell therapies for the treatment of chronic and life-threatening diseases, such as cancer.

The company was founded in 2014 and is headquartered in Somerset, New Jersey. Legend Biotech now employs over 2,400 people across six global manufacturing sites. Two of these sites are in Ghent: Obelisc (Technology Park Zwijnaarde) and Tech Lane (Eilandje Zwijnaarde).

In Ghent, Legend Biotech focuses on the production of advanced CAR-T cell therapies for the treatment of multiple myeloma, in close collaboration with Johnson & Johnson.

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.

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Purpose

Work in a global team of statistical experts to provide statistical support to Global Supply Chain sites and functions.
Focus on the delivery of statistical analysis required to support new product introduction (e.g. regulatory submissions, validation activities) and established products (e.g. root cause analysis investigations, batch quality assessments) aligned to the requirements of Product Lifecycle Management.
Act as an essential and accountable partner of cross-functional global teams (including investigations, task forces, improvement projects), management and key stakeholders in the organisation to provide statistical input to assessments and guide appropriate interpretation.
As a Subject Matter Expert in Statistics, help build the statistical capability of GSC across all sites and functions

Responsibilities

Support cross-functional global teams by providing statistical expertise to help interpret statistical outputs and use these alongside other scientific understanding to drive outcomes aligned to GSK values. This especially includes contribution to the resolution of deviations and improvement projects.
Carry out statistical analysis, report and communicate results and conclusions in the form of technical documents and presentations in accordance with regulatory and internal guidance. Take ownership and accountability of statistical content. Typical applications include study design and sample size calculation, process and method validation, assay or process trending, assay or process transfers.
Ensure compliance of data analyses with internal and external requirements (e.g. GSK QMS, GSK SOPS, Ph.Eur., ICH/FDA guideline).
Ensure integrity of statistical evaluation by ensuring application of appropriate statistical methodologies and traceability / reproducibility.
Contribute to local and global documents with statistical content, e.g. SOPs, guidelines.
Contribute to development and standardisation of data evaluation methodologies and conventions. This especially includes active participation with the wider statistics network (MSAT, Quality, TRD and R&D, as well as with the GPS community) to help ensure that best practises are incorporated into local ways of working.
Assist with upskilling ofl the organisation through coaching, mentoring and training of nonstatisticians and junior statisticians as required on the appropriate application of statistics and data evaluation tools for their business processes.

Knowledge, Skills & Experience

Master’s degree in Statistics, Data Science, Mathematics, or a related field.
At least 2 years of relevant experience in applying statistics, preferably in a pharmaceutical or manufacturing environment.
Proficiency in statistical software (e.g., SAS, R, JMP, Python).
Strong communication skills and ability to work collaboratively in cross-functional teams.

Preferred Qualifications:

PhD in Statistics or related field.
Experience with Quality by Design (QbD) principles.
Familiarity with biopharmaceutical processes or vaccines industry.
Experience in global teams and interdisciplinary environments.

To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore 

#Li-GSK 

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

Important notice to Employment businesses/ Agencies

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Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Latina, Italy

Job Description:

MSAT assistant scientist

Assistant Scientist – PKG (TD)

Johnson & Johnson is an American multinational company founded in 1886, a world leader in the development of products and devices for surgical therapies and pharmaceutical companies, as well as in the marketing of consumer products for personal hygiene, and is organized into three business segments: Pharmaceutical, Medical, Consumer.

Every day more than 120,000 employees work in 250 companies of the Group, located in 60 countries.

For the Italian production plant of Johnson & Johnson Innovative Medicine (Borgo San Michele-Latina) we are looking for an ASSISTANT SCIENTIST to be hired with a TEMPORARY CONTRACT in the MSAT DEPARTMENT.

The person will be part of the team who manage “New Product Introduction/ Technical Transfer” projects and will report to the MSAT Sr SPV.

Main responsibility

The Assistant Scientist is in charge of:

- As Project Leader ensure planning and coordination of the activities in collaboration with the various departments involved in the implementation of the projects.

- Proactively identifying risks to define mitigation strategies.

- Assess the business impact, quality, compliance and safety involving stakeholders from other departments.

- Ensure compliance with the time of introduction, balancing the base business production needs.

- Ensure timely communication to MSAT Sr Manager and Global Functions to align with the production plans themselves.

- Ensure the timely availability of quality documentation for the project execution.

- Performs and/or support investigations for non-conformances in case of occurrence during project activities.

Requirements

Master’s degree in Engineering, Farmacy, CTF or Chemistry
At least 6th month experience in the pharmaceutical industry (Oral Solid production is preferred)
Academic knowledge of lines, processes, materials and equipment for pharmaceutical process (oral solid pharma production competence is preferred).
Fluent in English (B2 level and above)
Good knowledge of quality, compliance and GMP related to manufacturing and packaging of pharmaceutical products.
Basic experience in Project Management.
Able to work in a multi-department and dynamic environment and to deal urgencies on the shop floor.
Ability to coordinate a cross functional team to ensure the correct execution of the project activities according to the agreed timing.
Skills of ownership and accountability
Skilled in problem-solving and decision making
Knowledge and basic experience in PAT, MVA and Chemometrics applications.
Fluent in English
Capacity to lead calls with costumers.
Capability to easily connect with people and prepare smart proposals for project approaches.
Excellent oral and written communication skills.
Ability to present scientific data and concepts effectively to international standards.

Use Your Power for Purpose

Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.

What You Will Achieve

In this role, you will:

Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications.
Conduct rigorous sampling and statistical process control procedures to identify deviations from standards.
Approve investigations and change control activities to maintain compliance with configuration management policies.
Contribute to moderately complex projects, managing time effectively and developing short-term work plans.
Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed.
Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.

Here Is What You Need (Minimum Requirements)

High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards
Strong critical thinking skills
Ability to work effectively within own team and interdepartmental teams
Good working knowledge of Microsoft Excel and Word
Proactive approach to problem-solving

Bonus Points If You Have (Preferred Requirements)

Experience in quality administered systems
Strong organizational skills and attention to detail
Experience with regulatory compliance and documentation
Ability to mentor and review the work of other colleagues

Preferred Education/ Qualification:

B.Pharm/ M.Pharm/ M.S (Pharmacy)/ M.Sc/ BE

Experience:

6+ years of experience in validation function of sterile dosage form facility.

Core Competencies:

Understanding of pharmaceutical manufacturing, packaging, quality assurance, and quality control operations.
Knowledge of validation principles and practices related to the following areas: manufacturing process, analytical method, cleaning methods, facility, equipment, instrument, utility system, and CSV systems.
Conversant with design & working principles of key equipment used in sterile manufacturing –Autoclave, Vial washing, Heat tunnel, Homogenizers, Vail filling, Filter integrity testing devices, Visual inspection equipment, Packing equipment, and Cleaning Validations.
Well versed with Terminal process – design, execution and review.
Experience in plant and TS operations.
Good document review skills, data analysis with ability to identify issues and recommend actions
Knowledge on the Qualification instruments and Tools.
Knowledge on the GAMP requirements, PDA guidance, ISO guideline, 21 CFR part 11.
Knowledge on the Components level assessment, PM requirement.
Good knowledge on the Validation instruments calibration.
Knowledge on the assessment of the Change controls and failure investigations.
Knowledge of current validation regulations in the industry and validation principles.
cGMPs and FDA regulatory guidelines.
Strong Technical skills, leadership, organizational planning and project management skills, in addition to strong technical background required to coordinate multi-disciplinary teams.
Strong interpersonal skills.
Excellent interpersonal effectiveness and communication skills (written and oral) to interface across departments and management levels.

Work Location Assignment: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control

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GSK Barnard Castle is a key secondary manufacturing site and has invested heavily in industry 4.0 state of the art, bespoke equipment to support sustained new product introductions and volume increases, and as a key supplier of some of GSK’s blockbuster products, the site contributes revenues of ~$2Bn annually.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

Are you energized by a highly technical manufacturing role that allows you to accelerate efficiency and shape product quality?  If so, this MSAT Drug Product Owner role could be an ideal opportunity to explore.

As a Drug Product Owner, you will Implement and maintain the product control strategy for a range of drug products (including small and large molecule drug products). You will be responsible for driving the production process lifecycle management for next generation and continuous improvement of drug product manufacturing.

In this role you will…

Provide technical oversight of our products and processes end-to-end, across sites, and throughout their lifecycle
Monitor the manufacturing process through Continuous Process Verification
Identify trends in the manufacturing process and implement pro-active technical solutions
Serve as the owner of product, process, and raw materials and ensuring the end-to-end view from incoming materials to finished product
Own Technical Risk Assessment (TRA) and the Product Control Strategy (PCS)
Lead process robustness and yield improvement projects

Why you? 

Basic Qualifications & Skills:

Bachelor’s degree in biology, biochemistry or chemistry
5 or more years of work in Good Manufacturing Practices (GMP) regulated pharma/biotech environment
Experience in Product Lifecycle Management
Experience with leading root cause analysis and evaluating variables influencing process performance

Preferred Qualifications & Skills:

Master’s degree in biology, biochemistry or chemistry
Ability to problem solve and identify technical/scientific solutions to resolve process-related issues
Strong interpersonal and relationship building skills
Ability to influence and gain support on complex issues

Closing Date for Applications: Thursday 24th July (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on UKRecruitment.Adjustments@gsk.com or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive

Important notice to Employment businesses/ Agencies

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Lead the timely and successful transfer of the cell culture or purification stages of the customer’s manufacturing process(es) into the Lonza Singapore production facility. Work with other MSAT team members, technical experts from Lonza’s customer companies or Lonza donor sites, Manufacturing (MFG or equivalent experience), Quality Assurance (QA), Quality Control (QC), and other departments on the technology transfer.
Process Support: Lead the preparation, execution, process monitoring, and post-campaign activities for cell culture or purification stages of the customer’s manufacturing processes at Lonza Singapore production facility. Become proficient with all processes in the facility and develop the ability to support/lead activities across multiple processes.
Monitor processes on a regular basis to further understand process behavior and prospectively identify process issues. Develop the ability to generalize issues across processes. Lead investigations into process trends, issues, or deviations involving multiple departments and customers. Write change requests and drive to implementation.
Review cell culture or purification process manufacturing batch records and provide technical input to MFG technical document writing specialists. Identify training needs and provide training materials for MFG operators on cell culture or purification process batch records.
Work with MFG to update process batch records to enable robust manufacturing operations. Support plant start-up and pilot/commercial runs, perform technical investigations, and help author technical reports to support close-out of deviations, trouble-shoot process excursions/issues for cell culture
SupportPreparation of Annual Product Review (APR) and Continued Process Verification (CPV) summary reports, perform work-stages to support customer BLA filing.
Maintain process databases and monitor batch-to-batch consistency of operations. Support inspections and audits by customers and regulatory authorities. Provide technical mentorship and share process knowledge with MSAT team members and other departments. Uphold data integrity principles in accordance with Lonza policies. Proactively evaluate, identify, and improve the data integrity process. Any other duties as assigned by your Supervisor/Manager.

What we are looking for:

Over 5+ years of experience in biotechnology process development, process support, research, or a related manufacturing environment.
Graduate degree in Chemical engineering, biochemical engineering, biochemistry/chemistry/biological science, or a related field.
Prior experience in technology transfer in the purification or cell culture domain.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.

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At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Die Möglichkeit

Im Bereich Basel Biotech Manufacturing stellen wir mit modernsten Anlagen Wirkstoffe zur Therapie von Krebs her. Die Abteilung Manufacturing Science and Technology (MSAT) ist eine Technologieeinheit zur Unterstützung der Produktion bei Basel Biotech Manufacturing. Die Herstellung und Durchführung dieser Prozesse finden mit Hilfe von hochautomatisierten Anlagen unter Einhaltung von cGMP statt.

In der Gruppe Materials der Abteilung Manufacturing Science & Technology (MSAT) innerhalb des Produktionsstandortes Basel Biologics Drug Substance bist Du für folgende Aufgaben zuständig:

Mitverantwortung für die Implementierung neuer Direct Materials (Prozess-Rohstoffe und produktberührende Materialien) in der Produktion und für MSAT Pilot.
Entwicklung, Modifizierung und Standardisierung von Prozessen und Methoden für die Herstellung und Anwendung von Materialien.
Festlegung von Designansätzen, Parametern und Spezifikationen sowie die Auswahl von Materialien basierend auf Zuverlässigkeitsanalysen.
Durchführung von Materialanalysen und Organisation experimenteller Tests zur Bestimmung von Betriebsdaten und zur Bewertung der Ergebnisse.
Bearbeitung und Untersuchung von Abweichungen, die mit Materialien zusammenhängen, sowie von GMP-relevanten Änderungen.
Kontinuierliche Verbesserung und Standardisierung der Single-Use Technology (SUT) Materialien im Hinblick auf Kosten, Verfügbarkeit, Einfachheit und Robustheit.
Erstellung aller notwendigen Dokumentationen und Verfahrensanweisungen für die Verarbeitung, das Testen und die Verwendung von Materialien.
Zusammenarbeit in globalen Teams und Arbeitsgruppen zum Thema Direct Materials und SUT.

Wer Du bist

Du bist erfahren in den Bereichen der kommerziellen biotechnologischen Wirkstoffherstellung und suchst eine Herausforderung im dynamischen Umfeld eines Produktionsstandortes für den Launch neuer Produkte mit neuesten Herstellungstechnologien (z.B. Single-Use Technology). Du zeichnest Dich als kommunikativer Teamplayer mit Flexibilität, Organisationstalent und Durchsetzungsvermögen aus.

Du bist eine leistungsorientierte Persönlichkeit, hast eine rasche Auffassungsgabe, eine strukturierte Arbeitsweise und besitzt die Fähigkeit zum analytischen Denken. Zu Deinen Stärken gehören ausserdem Selbstverantwortung, Qualitätsbewusstsein sowie unternehmerisches und ergebnisorientiertes Handeln.

Weiter verfügst Du über folgende Qualifikationen und Erfahrungen:

Abgeschlossenes Hochschulstudium in einem naturwissenschaftlichen Feld (z.B. Pharmazie, Biologie, Chemie), im Bereich des Ingenieurwesens (z.B. Biotechnologie, Verfahrenstechnik) oder eine abgeschlossene Berufsausbildung mit mehrjähriger Erfahrung mit Single-Use Technology im Produktionsbereich
Einschlägige Berufserfahrung (>5 Jahre) in der kommerziellen biotechnologischen Wirkstoffherstellung (Material Science)
Fachwissen der für die biopharmazeutische Industrie relevanten Standards und geltenden Qualitätsanforderungen (current Good Manufacturing Practice)
Erfahrungen im Bereich Materialeinführung und im Bereich Single-Use Technologie sind grundsätzlich von Vorteil
Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift
Versierter Umgang mit den gängigen IT Office Applikationen

Findest Du Dich hier wieder? Dann bist Du am Zug, bewirb Dich am besten jetzt!

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

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Use Your Power for Purpose

What You Will Achieve

In this role, you will:

Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications.
Conduct rigorous sampling and statistical process control procedures to identify deviations from standards.
Approve investigations and change control activities to maintain compliance with configuration management policies.
Contribute to moderately complex projects, managing time effectively and developing short-term work plans.
Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed.
Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.

Preferred Education/ Qualification: B.Pharm/ M.Pharm/M.S (Pharmacy)/M.Sc/ BE

Preferred Experience : 5-10 years of experience in Validation function of sterile injectable dosage form facility.

Core Competencies:

Conversant with design & working principles of key equipment used in sterile manufacturing –Autoclave, Vial washing, Depyrogenation tunnel, Homogenizers, Vail filling, Filter integrity testing devices, Vial Capping machine, Visual inspection equipment, Packing equipment, and Cleaning Validations.
Understanding of pharmaceutical manufacturing, packaging, quality assurance, and quality control operations.
Knowledge of validation principles and practices related to the following areas: manufacturing process, cleaning methods, facility, equipment, instrument, utility system, and CSV systems.
Well versed with Terminal process – design, execution and review.
Experience in plant and TS operations.
Preparation, Execution and review of DQ/FAT/SAT/IQ/OQ/PQ protocols and Reports.
Good document review skills, data analysis with ability to identify issues and recommend actions
Knowledge on the Qualification instruments and Tools.
Knowledge on the GAMP requirements, PDA guidance, ISO guideline, 21 CFR part 11.
Knowledge on the Components level assessment, PM requirement.
Good knowledge on the Validation instruments calibration.
Knowledge on the assessment of the Change controls and failure investigations.
Knowledge of current validation regulations in the industry and validation principles.
cGMPs and FDA regulatory guidelines
Strong Technical skills, leadership, organizational planning and project management skills, in addition to strong technical background required to coordinate multi-disciplinary teams.
Strong interpersonal skills.
Excellent interpersonal effectiveness and communication skills (written and oral) to interface across departments and management levels.
Can be able to develop and write validation Master Plan (VMP)/ Project validation plans (PVP) for the new facilities and periodic updation.

Work Location Assignment: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control

Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else.

At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Job Title: Manager MSAT Assembly & Packaging

Location: Uppsala, Sweden (Hybrid)

Job description :

In this role, you will manage a team of Assembly & Packaging manufacturing scientists responsible for new product implementation (NPI) into a manufacturing facility and for support of assembly and packaging processes during commercial manufacturing.
You and your team will demonstrate a strong process ownership by turning technologies into manufacturing capabilities by applied science and technical investigations, ensuring continuous process improvements through consistent methodology.

Key responsibilities:

You and your team are responsible for:

Implementing plans and programs and support policies and practices related to the end-to-end manufacturing processes of NPI projects at all stages, from prototyping to final stage
Enabling smooth transition of products from R&D into full production readiness, with team members representing MSAT in Technology Transfer projects and taking full process ownership
Ensuring suggested design made by engineering optimizes the production process in terms of process efficiency, cycle time, reliability, and serviceability
Process material for commercial production
Identifying and implementing assembly and packaging manufacturing processes for existing biologic and device injectable products
Process validation (PV), process trending programs, and continuous process verification (CPV) where applicable
Supplying technical manufacturing process expertise for appointed areas supporting daily operations, projects, regulatory applications, and audit presentations
Owning change controls within appointed area
Assessment and implementation of regulatory requirements according to List of Regulatory Requirements (LoRR)

As Manager MSAT T Assembly & Packaging, you will have extensive contact with other departments and external parties, and are expected foster cooperation and partnership to provide integrated solutions to problems. You will guide key stakeholders on processes, systems and tools, and are to develop strong, trusting cross-functional relationships with senior business leaders

Skills & Qualifications

BSc or MSc degree in a relevant engineering field and/or working experience in an industrial environment
Minimum of 8 years of experience in a biopharmaceutical/medical device or other regulated environment
Previous team management experience
Hands on experience with manufacturing processes, control strategies and product interactions in the medical device and/or biopharmaceutical industry.
Fluent in English and Swedish

What we offer in return

You will be working for an organisation that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.

As Galderma’s Global Center of Excellence for Aesthetics we have in Uppsala a unique edge as we have on our site the whole product chain from research and development to production and marketing. Here our nearly 600 employees work on our world leading brands such as Restylane, Azzalure and Sculptra.

We are offering you the opportunity to work in an exciting, international environment where both professional and personal development is encouraged. We are based in modern offices and located just by the river (Fyrisån) in Uppsala only a 10-minute bike ride from Uppsala Central Station.

Next steps

We welcome your application via our company website CAREERS | Galderma. Apply as soon as possible, as the selection process is ongoing continuously.

If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
The next step is an interview with the hiring manager 
The final step is a panel conversation with the extended team

Our people make a difference

At Galderma, you’ll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

","hiringOrganization":{"@type":"Organization","name":"Galderma","sameAs":"https://www.galderma.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Uppsala, Sweden","addressCountry":"Sweden","addressRegion":"Europe"}}}},{"@type":"ListItem","position":34,"item":{"@type":"JobPosting","title":"Manager MSAT Device Injectables","datePosted":"2025-08-18","description":"

Job Title: Manager MSAT Device Injectables

Location: Uppsala, Sweden (Hybrid)

Job description :

In this role, you will manage a team of Device Injectables manufacturing scientists responsible for new product implementation (NPI) into a manufacturing facility and for support of assembly and packaging processes during commercial manufacturing. You and your team will demonstrate a strong process ownership by turning technologies into manufacturing capabilities by applied science and technical investigations, ensuring continuous process improvements through consistent methodology.

Key responsibilities:

You and your team are responsible for:

Implementing plans and programs and support policies and practices related to the end-to-end manufacturing processes of NPI projects at all stages, from prototyping to final stage
Enabling smooth transition of products from R&D into full production readiness, with team members representing MSAT in Technology Transfer projects and taking full process ownership
Ensuring suggested design made by engineering optimizes the production process in terms of process efficiency, cycle time, reliability, and serviceability
Process material for commercial production
Identifying and implementing bulk and filling manufacturing processes for existing device injectable products
Process validation (PV), process trending programs, and continuous process verification (CPV) where applicable
Supplying technical manufacturing process expertise for appointed areas supporting daily operations, projects, regulatory applications, and audit presentations
Owning change controls within appointed area
Assessment and implementation of regulatory requirements according to List of Regulatory Requirements (LoRR)
Ownership for process material specifications for commercial production and product specifications
Ownership for E2E manufacturing processes including process risk assessments and post validation process descriptions
Ownership for medical device design control documentation following product design transfer

As Manager MSAT Device Injectables, you will have extensive contact with other departments and external parties, and are expected foster cooperation and partnership to provide integrated solutions to problems. You will guide key stakeholders on processes, systems and tools, and are to develop strong, trusting cross-functional relationships with senior business leaders

Skills & Qualifications

BSc or MSc degree in a relevant scientific or engineering field, such as Chemistry, Biochemistry, Chemical Engineering, or solid experience of working in a regulated industrial environment
Minimum of 8 years of experience with injectables in a biopharmaceutical and/or medical device environment
Previous team management experience
Fluent in English and Swedish

What we offer in return

You will be working for an organisation that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.

Next steps

We welcome your application via our company website CAREERS | Galderma. Apply as soon as the selection process is ongoing.

If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
The next step is an interview with the hiring manager 
The final step is a panel conversation with the extended team

Our people make a difference

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Job Title: External Supply MSAT Lead

Business Introduction
We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance.
Our network of 20+ contract manufacturing sites delivered 180 million packs of medicines and 4.5 billion units in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.
We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients

Position Summary
This role is an exciting opportunity to lead technical and operational excellence in external supply manufacturing. You will collaborate with cross-functional teams to ensure high-quality production, drive process improvements, and support regulatory compliance. We value candidates who are proactive, solutions-focused, and passionate about building capabilities in others.

Responsibilities

Lead and drive projects for new product introduction and line extensions
Provide technical leadership to external manufacturing partners, ensuring consistent product quality and compliance.
Drive process improvements and resolve technical challenges to enhance efficiency and reliability.
Support technology transfers, process validations, and troubleshooting activities.
Collaborate with internal and external teams to ensure alignment with regulatory and quality standards.
Lead investigations into deviations and implement corrective actions to prevent recurrence.
Build technical capabilities within the team and external partners through coaching and training.

Qualifications/Skills

Basic Qualifications

Bachelor’s degree in Engineering, Pharmacy, Chemistry, or a related field.
Minimum of 8 years of experience in manufacturing, science, and technology (MSAT) or technical operations.
Strong knowledge of Good Manufacturing Practices (GMP) and regulatory requirements.
Proven ability to solve complex technical problems using root cause analysis tools.
Excellent communication and collaboration skills.

Preferred Qualifications

Advanced degree in Engineering, Pharmacy, Chemistry, or a related field.
Experience in external supply manufacturing or working with contract manufacturing organizations (CMOs).
Knowledge of process validation, technology transfer, and continuous improvement methodologies.
Ability to lead and influence cross-functional teams in a matrix environment.
Familiarity with data analytics and digital tools to support decision-making.

We look forward to welcoming candidates who are eager to make a meaningful impact and grow with us.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Continuously looking for opportunities to learn, build skills and share learning.
Sustaining energy and well-being
Building strong relationships and collaboration, honest and open conversations.
Budgeting and cost-consciousness

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

Important notice to Employment businesses/ Agencies

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Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

Cilag AG, part of Johnson & Johnson Innovative Medicine, is hiring a Senior Validation Engineer in MSAT Biotherapeutics to enhance our team in Schaffhausen, Switzerland (100%, 12 months fixed-term contract).

Johnson & Johnson Innovative Medicine Schaffhausen Site/Cilag AG is a Launch site for new products with focus on Parenteral Products (e.g., pre-filled syringes and vials).

We belong to the Manufacturing Science & Technology (MSAT) organization for the MTO (Manufacturing and Technical Operations) Biotherapeutics and Synthetics Manufacturing Platform. We support the parenteral filling, visual inspection, device assembly and pack operations at J&J Innovative Medicine Schaffhausen.

Position Summary:

You will be the Site MSAT representative on multi-functional teams leading process validations of automated visual inspection of pre-filled syringes, vials and cartridges as well as device assembly and packaging processes of pharmaceutical products at the Schaffhausen Fill Finish site. This involves collaborating in cross-functional teams within the site and exchanging knowledge with other locations worldwide.

You will provide the following:

Technical support and leadership to top line growth
Ensure reliability, compliance & efficiency of product value chains end to end
Integrate manufacturing operations and pharmaceutical development in partnership with product and customer management

Responsibilities:

Site MSAT lead SME for Device Assembly, Packaging and (Automated) Visual Inspection
Accountable to meet project timelines during qualification and validation of visual inspection, device assembly and packaging lines and related processes.
Own validation activities with internal partners and lead multi-functional project teams.
Deliver on strategic project goals, process improvements and innovation to ensure competitiveness at the pharmaceutical market and with global players.
Provide Technical Assessments to Change Controls/CAPAs and Deviations.
Active participation in audits/health authority inspections as lead Subject Matter Expert.
Maintain excellent partnership with all business partners.
Perform statistical analyses on production data.

Qualifications:

You have successfully completed your university studies in Engineering, Chemistry, Pharmacy or equivalent and have already gained experience (5+ years) in the pharmaceutical sector with past proven field experience in process validation (ideally in visual inspection, device assembly and packaging).
You have proven experience in project execution, preferably in the live science and GMP environment. In addition to that you prefer an independent, self-initiative and goal-oriented way of working to apply your expertise and foster collaboration to reach fast paced goals according to management expectations and project schedules.
Your strength is decision making and problem-solving, combined with excellent communication skills to represent MSAT in multi-functional and cross-sites teams within the global matrix organization.
You are open to new ideas, and you drive innovation.
Proficient in both English and German is required.

Why join Johnson & Johnson

A multifaceted challenge in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure at the J&J Innovative Medicine site Schaffhausen.

Many opportunities to work on exciting projects and assignments in a dynamic work environment
A broad spectrum of training opportunities to grow further for personal as well as professional development
The Johnson & Johnson Pension Fund Switzerland offers attractive performance
A range of benefits for insurance, childcare, products, sport, culture and much more

Working at Johnson & Johnson is more than a job. We are changing the trajectory of Human Health and working with Johnson & Johnson can change everything. Including you. Learn more by watching this video.

#LI-MV2
#LI-Hybrid

Overview of role:

Are you passionate about downstream processing and ready to make a real impact in biopharmaceutical manufacturing? Alvotech is seeking a DSP MSAT Senior Specialist to support the successful transfer, optimization, and performance of biologics manufacturing processes at our state-of-the-art facility in Iceland.

Key Responsibilities:

Lead the Downstream tech transfer of manufacturing processes from internal sites to GMP scale at Alvotech Iceland.
Develop and document scale-up strategies for clinical and commercial manufacturing, including external sites if required.
Collect and analyze data for the CPV (Continued Process Verification) program and ensure consistent process performance and product quality.
Investigate deviations, identify root causes, and implement effective CAPAs.
Provide independent, on-the-floor technical support and complex data analysis to proactively resolve issues.
Represent MSAT in cross-functional internal and external project teams, driving technical solutions and effective collaboration.
Lead or support process optimization initiatives to improve yield, reduce cost, and enhance robustness.
Contribute technical expertise to project teams to ensure timely delivery of milestones.
Stay current with biopharmaceutical manufacturing technologies and introduce innovations that support process improvement.
Support process validation strategies and author/review SOPs and Process Description Documents (PDDs).
Ensure all activities are conducted in compliance with cGMP and EHS standards.

Qualifications:

Master of Science in Biotechnology or related field.
Knowledge of data analysis tools such as JMP and Minitab etc
Minimum 3 years of experience in the biopharmaceutical industry, with a focus on downstream processing (process development, manufacturing, or MSAT).
Strong expertise in industrial biotechnology and monoclonal antibody manufacturing.
Solid understanding of GMP environments and regulatory expectations.

What we offer:

An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
The chance to be a part of a global and fast-growing company.
An international work culture that encourages diversity, collaboration and inclusion.
Positive, flexible, and innovative work environment.
Support for personal growth and internal career development.
Company social events and milestone celebrations.
Excellent in-house canteen and coffee house.
Exercise and wellbeing support for full-time employees.
On-site shower facility.
Transportation grant towards eco-friendly modes of travel for full-time employees.
Internet at home for full-time employees.

Why Alvotech

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.

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Overview of role:

Are you a subject matter expert in upstream processing with a passion for innovation and technical excellence in biologics manufacturing? Alvotech is seeking a USP MSAT Specialist – Late Stage to lead upstream process support, scale-up, and lifecycle management for commercial biosimilar products.

Key Responsibilities:

Act as the Subject Matter Expert (SME) for upstream manufacturing processes.
Investigate complex upstream deviations, perform root cause analysis, and implement CAPAs.
Author and review process documentation including Process Description Documents (PDDs), protocols, reports, change controls, and regulatory filings.
Provide independent technical support on the manufacturing floor, monitor processes, and analyze data to anticipate and resolve issues.
Lead process scale-up and technology transfer from small-scale to GMP manufacturing across clinical and commercial stages.
Assess and qualify new materials and alternate raw materials for upstream processes.
Support the introduction and qualification of new processes into GMP manufacturing, managing technical risks and leading cross-functional teams.
Contribute to lifecycle management of commercial biosimilars, including Continued Process Verification (CPV) and process changes.
Represent MSAT in internal and external project teams, driving technical solutions and ensuring successful outcomes.
Stay current with biopharmaceutical manufacturing technologies and introduce innovations to improve yield, cost-efficiency, and process robustness.
Support regulatory submissions and product approval processes.
Ensure all activities are conducted in compliance with cGMP and EHS standards.

Qualifications:

Master’s degree in Life Sciences (Biotechnology or related field).
5–10 years of experience in the biopharmaceutical industry, with a focus on upstream processing, process development, manufacturing, or MSAT.
Strong knowledge of monoclonal antibody manufacturing and industrial biotechnology.
Experience in GMP environments and regulatory compliance.
Proven ability to work independently, manage complex technical challenges, and lead cross-functional teams.

What we offer:

An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
The chance to be a part of a global and fast-growing company.
An international work culture that encourages diversity, collaboration and inclusion.
Positive, flexible, and innovative work environment.
Support for personal growth and internal career development.
Company social events and milestone celebrations.
Excellent in-house canteen and coffee house.
Exercise and wellbeing support for full-time employees.
On-site shower facility.
Transportation grant towards eco-friendly modes of travel for full-time employees.
Internet at home for full-time employees.

Why Alvotech

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Use Your Power for Purpose

As a Senior Associate, you will play a crucial role in improving patients' lives while working at Pfizer. Your contributions will directly impact the development and delivery of innovative solutions that enhance the quality of life for patients worldwide. Join us in our mission to bring breakthroughs that change patients' lives.

What You Will Achieve

In this role, you will:

Handle Technology Transfer activities & New Product Introduction process
Knowledge of validation and practices related to the manufacturing process, analytical method, cleaning methods, facility, equipment, instrument, utility system, and CSV systems.
Conversant with design & working principles of upstream equipment used in sterile manufacturing –solution preparation, vial washing, heat tunnel, homogenizers, filling machines, filter integrity testing devices autoclave and cleaning validations.
Well versed with Manufacturing process – design, execution, and review.
Understanding of pharmaceutical manufacturing, quality assurance, and quality control operations.
Knowledge in parenteral formulation development like liquid/ dry powder and lyophilized formulations
Experience in plant and TS operations
Good document written skills, with ability to identify issues and recommend actions.
Good grasping power of technical matters

Here Is What You Need (Minimum Requirements)

6+ years of experience in tech transfer activities and /or validation function with any degree of B.Pharm/ M.Pharm/ M.S (Pharmacy)/ M.Sc/ BE.
Must have an experience of sterile dosage form facility / Formulation Development/ Product Development/ Process Development/ manufacturing of Injectable formulations to cater regulated market, essentially experience in Plant Technology Transfer support in Injections.
Knowledge of validation and practices related to the manufacturing process
Strong technical skills in process development and optimization
Proficiency in data analysis and interpretation
Experience with project management tools and methodologies
Knowledge of regulatory requirements and compliance standards
Ability to work collaboratively in a team environment
Strong communication skills, both written and verbal
Proficiency in Microsoft Office Suite

Bonus Points If You Have (Preferred Requirements)

Experience in the pharmaceutical or biotechnology industry
Familiarity with Good Manufacturing Practices (GMP)
Experience with statistical software (e.g., Minitab, JMP)
Ability to lead cross-functional teams
Strong organizational skills
Adaptability and flexibility in a dynamic work environment
Ability to mentor and develop junior team members

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Engineering

Job Description

General Summary:

The Director, Analytical Sciences and Technology (Small Molecule Drug Product) is a leader and subject matter expert who represents the analytical function for multiple product areas in cross-functional and external settings. The director provides technical and strategic leadership across global test sites for analytical, process, and CMC functions, primarily focused on small molecule commercialization and global expansion including SDDs and Formulation-Drug Product. The Director has central responsibility for analytical and testing support for global manufacturing operations, overseeing activities of staff, and adapting personnel deployment to changing priorities. They take a leadership role in department-wide initiatives and guide the resolution of critical issues impacting manufacturing and analytical operations.

The position reports directly to the Senior Director of Analytical Sciences and Technology.

Key Duties and Responsibilities:

Responsible for all aspects of the team(s) and manages activities of the team(s) across project boundaries
Manage, support, mentor, hire and develop scientist within their team
Represent Analytical Science and Technology on cross-functional CMC sub-teams, with minimal guidance, to influence late-stage process/product development and minimize subsequent commercialization risk
Lead and direct the plans and activities of their DP functional area, ensuring safe and GMP-compliant operations that adhere to budget and schedule.
Recognized as subject matter expert and acts as a resource in one or more technical areas
Provide analytical expertise for global expansion, commercial supply, and regulatory submissions
Expertise in analytical strategy and methodologies for DP release, stability, and characterization testing. Responsible for commercial drug product analytical methods, specifications, and global impact of product stability and shelf-life.
Own Drug product analytical method validations, analytical method transfers, in-country testing, and associated activities/documentation
Actively drive best practices and continuous process improvement for programs & processes on behalf of AS&T
Support process transfers to new CMOs and analytical support for second-source activities and problem-solving/root cause analysis
Provide scientific and technical input to assess potential business opportunities, new ventures, and product development. Identify areas or equipment and capabilities the team should consider for evaluation and commercialization.
Author, review, and approve technical, quality, and regulatory documentation.
Understanding of the fundamentals of QbD, the use of DOEs in process development and commercial, and the implications of criticality and thresholds on the commercial functions
Assist with and lead the resolution of quality investigations, change controls, CAPAs, and Quality events
Ensure positive relationships with key suppliers, stakeholders and represent the department on cross-functional teams. Work with groups such as Quality, Supply Chain, Regulatory, Pharmaceutical Development, contract partners, etc. to proactively resolve issues that may negatively impact project timelines or deliverables
Participate in the scientific community by attending conferences and being on external committees to support the company strategy of being best in class

Knowledge and Skills:

Excellent interpersonal and collaboration skills
Knowledge of cGMPs and associated CMC regulatory considerations in a pharmaceutical environment
Proven ability to interact effectively and give presentations to senior management
Demonstrated flexibility to accommodate changes in responsibilities or project priorities
Proven ability to lead and manage projects of high complexity including the development of and adherence to timelines and budget
Fosters a team environment of confidence and commitment and models the core values throughout the organization
Knowledgeable in technical areas outside the main area of expertise
Proven supervisory experience and track record of enabling career development of staff

Education and Experience:

Small molecule experience
Bachelor's degree, Master's degree, or PhD in Analytical Chemistry or related field.
Ph.D. (or equivalent degree) and 10 years of relevant post-doctoral employment experience, or
Masters Degree (or equivalent degree) and 13 years of relevant employment experience, or
Bachelor's Degree (or equivalent degree) and 15 years of relevant employment experience

Pay Range:

$188,000 - $282,000

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

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Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions à l’international, l'anglais étant la langue de travail.

This job offer is accessible to all, regardless of gender.

Location: Aramon, FR
Hiring Manager: Simon Banks, Head of MSAT Synthetics and Solids
Job Type: Permanent

About the job

Are you ready to shape the future of medicine? Transform healthcare through groundbreaking science! Join Sanofi's Global MSAT (Manufacturing Sciences, Analytics, and Technology) team, where innovation meets implementation. As Head of the MSAT DS Synthetics, you'll orchestrate the crucial bridge between R&D brilliance and manufacturing excellence, leading process development, industrialization, and supply activities that turn scientific potential into life-changing treatments.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. Here, you'll thrive in an environment where breakthrough thinking is celebrated, where your career can flourish across diverse paths, and where every day brings opportunities to push the boundaries of what's possible. Ready to make your mark?

Digital & AI Leadership:

Pioneer AI-powered solutions that revolutionize process optimization and control
Champion and implement transformative digital initiatives across MSAT operations
Create powerful data-driven decision-making frameworks
Champion advanced analytics and predictive modeling for breakthrough results

Launch Excellence

Drive 3-5 groundbreaking products from concept to reality annually
Deliver seamless product journeys from early development to commercial success
Ensure technology transfers and scale-up operations deliver with precision
Transform scientific potential into commercial reality through digital innovation

Main responsibilities:

Lead process development and scale-up to support clinical trials, launch and commercial manufacturing of small molecule drug substances.
Ensure scientific excellence and regulatory compliance in data generation, submissions, and lifecycle activities.
Drive innovation and second-generation process development to enhance performance, sustainability, and supply continuity.
Provide technical support to commercial manufacturing and ensure robustness in troubleshooting and strategic investments.
Oversee technology transfers from R&D and external partners to industrial production sites.
Manage resources, budgets, and cross-functional teams to deliver on strategic objectives and operational execution.
Advance talent development and a culture of safety, quality, and continuous improvement across the development organization.
Represent MSAT in site governance and global networks.
Drive and execute the strategic direction of Environmental Sustainability by Design initiatives with the organization, fostering a culture of environmental sustainability and innovation in pharmaceutical development.

About you

PhD or master's degree in chemical engineering, organic chemistry or related scientific field.
Minimum 10 years of experience in pharmaceutical process development or MSAT.
Demonstrated leadership in managing technical teams and cross-functional projects.
Expertise in chemical process development, scale-up, technology transfer and manufacturing support.
Solid understanding of small molecule manufacturing operations, GMP, CMC regulations, and HSE requirements.
Strategic thinking with the ability to manage complexity and ambiguity.
Excellent communication, team leadership, and stakeholder management skills.
Proven ability to drive innovation and promote a culture of scientific curiosity and continuous improvement.
Track record of transformational leadership in matrixed organizations
Experience with flow chemistry methodology
English: Fluent
French: Proficiency is a plus

Why choose us?

Be part of a mission that transforms scientific breakthroughs into life-changing treatments
Chart your own course in a dynamic environment that supports both vertical and horizontal career growth
Thrive with a comprehensive rewards package that recognizes and amplifies your impact
Experience peace of mind with premium healthcare, innovative wellness programs, and industry-leading parental leave
Lead the charge in AI innovation, shaping the future of pharmaceutical development
Make a tangible impact by bringing multiple new products to patients annually
Drive excellence across a €10B+ portfolio using cutting-edge digital solutions

Pursue Progress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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Basic Qualifications:

Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk
Managing individual and team performance.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Implementing change initiatives and leading change.
Sustaining energy and well-being, building resilience in teams.
Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
Developing people and building a talent pipeline.
Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
Budgeting and forecasting, commercial and financial acumen.
Bachelor’s degree or above in engineering, manufacturing technology, pharmaceutical science or equivalent field.
Experience with at least 10-16 years in drug/device combination (DDC) product and/or medical device development, pharmaceutical development, biotechnology, manufacturing, and/or quality (open to experience in pharmaceutical development experience, or other regulated industry, as an alternative). A minimum of 3-5 years working in the field of DDC and/or medical device development, DDC and/or medical device manufacturing, and/or lifecycle management of DDCs and/or medical devices is also required.
Technical knowledge and familiarity with product development processes, specifically the evaluation of DDCs and/or medical devices and/or manufacturing processes.
Knowledge of sterile drug product primary pack & devices, qualification process.
Experience with Design History File (DHF) assembly, maintenance, and/or remediation
Strong project management, organizational, and time management skills. Proven ability to manage time effectively, prioritize tasks appropriately, and proactively communicate priorities and efforts with team members and supervisor.
Experience managing documents, databases, and using tracking tools.
Knowledge and understanding of Good Manufacturing Practice (GMP), Pharmacopeia and regulatory standards including EU MDR 2017/745, 21 CFR part 4, 820, 210/211, ISO 13485, ISO 14971, and/or IEC 60601.
Experience supporting regulatory audits.
Design control and risk management experience.
Flexibility to face rapidly changing requirements and reprioritize based on stakeholder input.
Ability to work in a matrix international organization.
Written and oral fluency in English, with strong verbal and written communication skills.
Competence with full MS Office Suite (Word, Excel, Outlook, PowerPoint).

Preferred Qualifications:
Manufacturing Science and Technology (MSAT) is responsible for ensuring that products are produced safely, efficiently, and to the highest quality standards. The GSK MSAT team plays a vital role in ensuring that manufacturing processes are efficient, reliable, and compliant with regulatory standards, ultimately contributing to the successful production of high-quality pharmaceutical and biopharmaceutical products

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

Important notice to Employment businesses/ Agencies

","hiringOrganization":{"@type":"Organization","name":"GSK","sameAs":"https://www.gsk.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bengaluru Luxor North Tower, India","addressCountry":"India","addressRegion":"Asia/Pacific"}}}},{"@type":"ListItem","position":43,"item":{"@type":"JobPosting","title":"MSAT Process Science Scientist - Maternity Replacement","datePosted":"2025-07-21","description":"

We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

Scope
Operate and perform in a broad range of varied Process Science work activities that support the team, department, and company objectives. This includes laboratories working within the required operational areas, working closely alongside Associates at all levels, coaching, mentoring, and driving standards where required. The role holder will be responsible for driving and implementing downscale models and process improvements based on the Quality by Design approach.

In this role, you will:

Develop small-scale models for supporting troubleshooting activities and process improvements to enhance manufacturing process robustness.
Work closely within Process Science work areas and in a cross-functional environment (MSAT Manufacturing Support & Stewardship, Manufacturing, Quality, Engineering, and TRD).
Plan/prioritize the laboratories' work of the Department/Team, accordingly to Process Science Leads, providing feedback as necessary. Work activities must meet the required standards of the area and maintain healthy, safe, and productive working conditions.
Actively develop their own skills to stay up-to-date in their area of specialization, improve performance, and manage their own time to ensure objectives are met. Contribute to the development of the team by adequately transferring their specialist knowledge to other team members.
Propose and apply innovative technologies (e.g., PAT, SuS, etc.) to improve manufacturing process robustness.
Create effective working relationships by gaining the support and trust of their manager, colleagues, and team members.
Ensure appropriate standards of GMP, housekeeping, and safety are applied within their area, in accordance with GSK guidelines.
Get involved in ad hoc projects (Process Robustness/improvements, Tech Transfer, and Methods Development) as a referent person (SPOC and/or SME).

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

Degree in Engineering, Pharmaceutical Technology, Pharmacy or equivalent scientific degree with solid industry experience
Proven experience in a process development support role
Spoken & written English and Italian.

Preferred Qualifications:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

Proven process understanding (small-scale vaccines/biologics, GMP, Regulatory aspects)

What we Offer:

Maternity replacement in a very Inclusive environment
Smart Working up to 50% for eligible roles
Performance Reward
Flexible Benefits
Company Healthcare Plan
Integrative pension fund
Employee Assistance Programme
Prevention services and vaccination clinic
Local nursery agreement
Postal service, laundry, shoe repair and tailoring
On site canteens and coffee corners
Free company bikes and shuttle

Please note that relocation support cannot be provided; therefore, only candidates who are already based in the indicated country can be considered.

Closing Date for Applications – 4th August 2025

Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

#LI-Hybrid

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

Important notice to Employment businesses/ Agencies

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Basic Qualifications:

Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk
Managing individual and team performance.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Implementing change initiatives and leading change.
Sustaining energy and well-being, building resilience in teams.
Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
Developing people and building a talent pipeline.
Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
Budgeting and forecasting, commercial and financial acumen.
Bachelor’s degree or above in engineering, manufacturing technology, pharmaceutical science or equivalent field.
Experience with at least 10-16 years in drug/device combination (DDC) product and/or medical device development, pharmaceutical development, biotechnology, manufacturing, and/or quality (open to experience in pharmaceutical development experience, or other regulated industry, as an alternative). A minimum of 3-5 years working in the field of DDC and/or medical device development, DDC and/or medical device manufacturing, and/or lifecycle management of DDCs and/or medical devices is also required.
Technical knowledge and familiarity with product development processes, specifically the evaluation of DDCs and/or medical devices and/or manufacturing processes.
Knowledge of sterile drug product primary pack & devices, qualification process.
Experience with Design History File (DHF) assembly, maintenance, and/or remediation
Strong project management, organizational, and time management skills. Proven ability to manage time effectively, prioritize tasks appropriately, and proactively communicate priorities and efforts with team members and supervisor.
Experience managing documents, databases, and using tracking tools.
Knowledge and understanding of Good Manufacturing Practice (GMP), Pharmacopeia and regulatory standards including EU MDR 2017/745, 21 CFR part 4, 820, 210/211, ISO 13485, ISO 14971, and/or IEC 60601.
Experience supporting regulatory audits.
Design control and risk management experience.
Flexibility to face rapidly changing requirements and reprioritize based on stakeholder input.
Ability to work in a matrix international organization.
Written and oral fluency in English, with strong verbal and written communication skills.
Competence with full MS Office Suite (Word, Excel, Outlook, PowerPoint).

Preferred Qualifications:
Manufacturing Science and Technology (MSAT) is responsible for ensuring that products are produced safely, efficiently, and to the highest quality standards. The GSK MSAT team plays a vital role in ensuring that manufacturing processes are efficient, reliable, and compliant with regulatory standards, ultimately contributing to the successful production of high-quality pharmaceutical and biopharmaceutical products

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

Important notice to Employment businesses/ Agencies

","hiringOrganization":{"@type":"Organization","name":"GSK","sameAs":"https://www.gsk.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bengaluru Luxor North Tower, India","addressCountry":"India","addressRegion":"Asia/Pacific"}}}},{"@type":"ListItem","position":45,"item":{"@type":"JobPosting","title":"Technical Fellow (Director), Advanced Therapies - MSAT","datePosted":"2025-08-08","description":"

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Technical Fellow (Director), Advanced Therapies - MSAT to be in Raritan, NJ, Titusville, NJ, Malvern, PA, or Spring House, PA.

Purpose:

The Technical Fellow serves as a subject matter expert (SME) in CAR-T manufacturing and Quality Control analysis, playing a pivotal role in ensuring the quality and safety of cellular therapies. This position is critical in addressing challenges that arise when non-conforming products or deviations are generated during the manufacturing process, which can impact patient treatment. The Technical Fellow actively engages with healthcare providers to navigate these challenges, facilitating clear communication and collaborative problem-solving.

In addition to direct interaction with healthcare providers, the Technical Fellow curates and analyzes manufacturing case studies to expedite the release of drug products. This role requires deep expertise in key areas, including apheresis collection, cryopreservation, cell processing, quality control testing, and quality release processes. The Technical Fellow provides insights to both internal manufacturing teams and external partners, ensuring adherence to the highest standards of quality.

The Technical Fellow is also an integral member of various site/network operational teams, including planning, release, clinical/commercial rapid response teams, safety management, and site escalations. In this capacity, they contribute to the development of robust strategies that maintain the validated state of cell therapy processes while supporting lifecycle management initiatives involving new technologies, automation, and technology transfer.

Finally, this role serves as a key thought leader and scientific expert driving manufacturing trend investigation teams towards root cause identification. Proactively identifying complex scientific correlations linking deep univariate and multivariate data analyses to T-cell biology fundamentals, these role partners with development and site technical operations teams to drive towards robust conclusions. Through successful investigation, complex trends can be addressed by reducing non-conformance rates, aiding patients in need of rapid treatment.

This position is essential for enabling the CARVYKTI network's technical, supply chain, and compliance-related objectives. Collaborating across a complex network of internal and external stakeholders, this role drives improvements in patient care and enhances the overall efficiency of CAR-T therapy delivery.

You will be responsible for:

Provide deep subject matter expertise to batch advocacy efforts for non-conforming products, leading manufacturing trend investigations and supporting root cause identification
Engage with key opinion leaders in cell therapy space, academics, physicians, hospital/medical centers lead to drive down patient related contributions to non-conforming product. Engage with new markets to set up for success during the initial launch period (aiding in education on patient factors/contributions to manufacturing success)
Provide deep subject matter expertise on initiatives aimed at reducing non-conforming product rates, through projects that may/may not require regulatory approval
Provide technical support to regulatory filings, regulatory inspections, and health authority questions.

Qualifications:

PhD in Chemical Engineering, Microbiology, Cell Biology, or related with 10-12 years of overall experience is required; 7+ years of biotech/pharmaceutical experience or equivalent industry experience is highly preferred.

Hands-on experience in Manufacturing Operation and/or R&D in a biopharmaceutical manufacturing setting (ie. cell/gene therapy products, vaccines, or any other advanced therapy products)
Experience working with contract partners and internal manufacturing sites
Expert knowledge of T-cell biology
Expert knowledge of cell and gene manufacturing processes
Expert knowledge of GMP/quality considerations for commercial manufacturing
Expert knowledge of evolving ATMP health authority expectations/regulations
This role may require up to 20% of domestic or international travel.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

The anticipated base pay range for this position is :

$146,000 to $251,850 Annual

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. •\tEmployees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). •\tEmployees are eligible for the following time off benefits: o\tVacation – up to 120 hours per calendar year o\tSick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year o\tHoliday pay, including Floating Holidays – up to 13 days per calendar year o\tWork, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.","hiringOrganization":{"@type":"Organization","name":"Johnson & Johnson","sameAs":"https://www.jnj.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"US065 NJ Raritan - 700 Route 202 S, United States","addressCountry":"United States","addressRegion":"North America"}}}},{"@type":"ListItem","position":46,"item":{"@type":"JobPosting","title":"MSAT Sterile Technical Specialist (Visual Inspection)","datePosted":"2025-08-21","description":"

We embrace modern work practises with our Performance with Choice programme. This role is site based and may require occasional shift support.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

As the BC MSAT Site Automated visual inspection and leak detection lead you will be responsible for managing and delivering the NPI visual inspection portfolio, including the development and validation of both inspection and leak detection equipment. Additionally, this role involves developing manual visual inspection processes, including the training and qualification of manual visual inspectors. You will work across the site to ensure strong relationships with wider technical, engineering, and quality functions.

In this role you will…

Serve as the expert on visual inspection and leak detection issues, offering specialised knowledge in this field.
Maintain knowledge of innovative technology and best practices for visual inspection and leak detection.
Coach and mentor Technologists and others working in wider technical teams, engineering teams, and quality functions.
Continually monitor and assess process capabilities using data to enhance inspection technical process capability. Possess comprehensive knowledge of the MVI, AVI, and LD processes and equipment, and understand how these processes interact with other operations on site
Establish and implement standards and procedures to ensure compliance with Quality and EHS regulatory standards.
Ensure day-to-day technical issues are resolved urgently to minimise impact on project(s)/product performance or reject/waste levels

Why you? 

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

Bachelors/Masters degree in Chemistry, Biology, Engineering or a related field, accompanied by substantial technical or industry experience.
Experience in inspection technology methodologies sterile products.
Excellent problem-solving and analytical skills.
Effective communication and teamwork abilities.
Familiarity with cGMP, industry standards and regulatory requirements.

Preferred Qualifications & Skills:

Preferred experience in life science, biotechnology, pharmaceutical or other regulated industry.
PHD in Chemistry, Biology, Engineering or another related field with industry experience.
Strong knowledge of lean manufacturing, Six Sigma, and other process improvement methodologies.
Knowledge of Product Lifecycle Management business processes, including QbD approach, product dose forms, manufacturing processes, and Technology Transfer.

Closing Date for Applications: 4th September 2025 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Important notice to Employment businesses/ Agencies

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Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking Scientist I – MSAT (Cell & Gene Therapy) as part of the Manufacturing Technology team based in Somerset, NJ.

Role Overview

We are seeking a motivated Scientist I to join our MSAT team, supporting the development, troubleshooting, and optimization of automated manufacturing processes for CAR-T and other cell therapy products. Under the guidance of senior staff, this role will perform bio-pilot run experiments, technology evaluations, and process improvement studies. The position will directly contribute to manufacturing robustness and efficiency by executing laboratory work, assisting in equipment testing, and analyzing process data.

Key Responsibilities

Execute bench-scale experiments for bio-pilot run comparisons, technology evaluations, and process improvement initiatives.
Operate and assist in troubleshooting closed-system and automated platforms (e.g., Prodigy, Rotea, Cue, Lovo, G-Rex).
Perform and interpret analytical assays, including flow cytometry, qPCR, ELISA, and other cell-based methods, to support process evaluation and comparability.
Collect, analyze, and summarize experimental data (cell growth, viability, metabolite trends) using statistical tools.
Support preparation of study protocols, technical reports, and SOPs in compliance with GMP standards.
Assist in process troubleshooting and root-cause investigations for manufacturing and automation systems.
Maintain a safe, organized, and compliant laboratory workspace.
The role makes independent decisions regarding routine laboratory execution, minor troubleshooting, and data analysis within approved study protocols. Guidance is sought from senior team members for experimental design, major troubleshooting steps, and changes to validated processes.

\n\n\n

Requirements

Bachelor’s degree in biotechnology, Bioengineering, Molecular Biology, or related discipline
2-4 years’ experience in cell culture (T-cells, immune cells, or primary cells) in an academic, process development, or GMP environment.
Hands-on experience with aseptic technique and biosafety cabinet work.
Exposure to closed-system or automated manufacturing platforms preferred (e.g., Prodigy, Rotea, Cue, Lovo).
Hands-on experience with analytical assays (flow cytometry, qPCR, ELISA) in a cell therapy, immunology, or bioprocess setting.
Experience in basic analytical methods such as cell counting, viability assays, and metabolite monitoring.
Familiarity with data analysis and preparation of technical documentation.
Proficiency with Microsoft Office (Excel, Word, PowerPoint).
Basic data analysis using Excel, JMP, or similar tools.
Ability to interface with instrument control software.

#Li-BZ1

#Li-Hybrid

Benefits:

We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

EEO Statement

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.

Legend Biotech maintains a drug-free workplace.

","hiringOrganization":{"@type":"Organization","name":"Legend Biotech","sameAs":"https://legendbiotech.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Somerset, New Jersey, United States","addressCountry":"United States","addressRegion":"North America"}}}},{"@type":"ListItem","position":48,"item":{"@type":"JobPosting","title":"Associate Scientist MSAT (Cell & Gene Therapy)","datePosted":"2025-08-19","description":"

Legend Biotech is seeking Associate Scientist MSAT (Cell & Gene Therapy) as part of the Manufacturing Technology team based in Somerset, NJ.

Role Overview

We are seeking a motivated Associate Scientist to join our MSAT team, supporting the development, troubleshooting, and optimization of automated manufacturing processes for CAR-T and other cell therapy products. Under the guidance of senior staff, this role will perform bio-pilot run experiments, technology evaluations, and process improvement studies. The position will directly contribute to manufacturing robustness and efficiency by executing laboratory work, assisting in equipment testing, and analyzing process data.

Key Responsibilities

Execute bench-scale experiments for bio-pilot run comparisons, technology evaluations, and process improvement initiatives.
Operate and assist in troubleshooting closed-system and automated platforms (e.g., Prodigy, Rotea, Cue, Lovo, G-Rex).
Perform and support analytical assays such as flow cytometry, qPCR, ELISA, and cell counting to evaluate product quality and process outcomes.
Collect, analyze, and summarize experimental data (cell growth, viability, metabolite trends) using statistical tools.
Support preparation of study protocols, technical reports, and SOPs in compliance with GMP standards.
Assist in process troubleshooting and root-cause investigations for manufacturing and automation systems.
Maintain a safe, organized, and compliant laboratory workspace
The role makes independent decisions regarding routine laboratory execution, minor troubleshooting, and data analysis within approved study protocols. Guidance is sought from senior team members for experiment design, major troubleshooting steps, and changes to validated processes

\n\n\n

Requirements

Bachelor’s degree in biotechnology, Bioengineering, Molecular Biology, or related discipline
1–2 years of hands-on cell culture (T-cells, immune cells, or primary cells) experience in academic, process development, or GMP labs.
Hands-on experience with aseptic technique and biosafety cabinet work.
Experience in basic analytical methods such as cell counting, viability assays, and metabolite monitoring.
Familiarity with data analysis and preparation of technical documentation.
Exposure to automated/closed-system platforms preferred.
Strong organizational and documentation skills.
Proficiency with Microsoft Office (Excel, Word, PowerPoint).
Basic data analysis using Excel, JMP, or similar tools.
Ability to interface with instrument control software

#Li-BZ1

#Li-Hybrid

Benefits:

EEO Statement

Legend Biotech maintains a drug-free workplace.

","hiringOrganization":{"@type":"Organization","name":"Legend Biotech","sameAs":"https://legendbiotech.com/"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Somerset, New Jersey, United States","addressCountry":"United States","addressRegion":"North America"}}}},{"@type":"ListItem","position":49,"item":{"@type":"JobPosting","title":"Intern MSAT Bio DP (M/F)","datePosted":"2025-08-22","description":"

Job Function:

Career Programs

Job Sub Function:

Non-LDP Intern/Co-Op

Job Category:

Career Program

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

POSITION SUMMARY:

As an MSAT Cleaning Validation Intern, you will support other team members in developing, maintaining, and preparing reliable cleaning processes for product- and indirect-product contact parts to meet future requirements. This involves support of colleagues in collaborating in cross-functional teams within the site and exchanging knowledge with other locations worldwide.

KEY RESPONSIBILITIES:

Support the development and validation of cleaning processes for new products.
Support the development and validation of improved cleaning processes for existing products.
Support the development and implementation of new strategies for cleaning validation.
Support the creation of documents for cleaning validation activities (protocols, reports, risk assessments, SOPs).
Coordinate cleaning validation activities with other departments.
Support calculations for permissible limits for cleaning validation.
Support investigations and change controls.
Support the preparation of technical assessments for investigations and change controls.
Contribute to the digital transformation of MSAT (e.g., digitization and automation of reports, data management, visualization, evaluation of new technologies)

Qualifications:

As an ideal candidate, you have:

Completed academic high school and are planning to or currently in the course of obtaining a Bachelor’s or Master’s degree in Life Sciences or Engineering.
A keen interest in gaining insights into the pharmaceutical industry.
A keen interest in gaining insights into the topic of cleaning validation and collaboration with different departments (operations, engineering, quality department, etc.).

You are:

Proficient in German and English, both in communication and negotiation.
Customer-oriented and quality-conscious.
Strong in decision-making and problem-solving.
An innovative team player who can propose creative and pragmatic solutions.
Interested in digital transformation and capable of proposing and implementing corresponding process improvements.

We offer:

The opportunity to gain insight into a dynamic, international environment with attractive conditions and career opportunities, as well as good infrastructure at the Schaffhausen site.
Many opportunities to work on exciting projects and assignments.
Support for childcare.
A wide range of training opportunities for personal and professional development.

Position: MSAT Engineer Trainee (Career Conversion Program)

Hiring Manager: Head of MSAT
Location: Modulus - Tuas, Singapore

Our Team

Sanofi Manufacturing and Supply Organization is preparing its future through an ambitious program named Modulus. The Modulus Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine business challenges as well as Specialty Care biological products. One of these two Modulus sites is implemented in Singapore in a new Greenfield site, with a design identical to the one in Neuville (France). Our manufacturing sites are state-of-the-art, powered by big data and digital. It is the bridge between scientific advances and transformative medicines and will be serving millions of people around the world.

Manufacturing Science, Analytics & Technology (MSAT) drives the industrialization and the improvement of biological processes and products. It embarks new technologies and digital trends. It is the keeper of manufacturing process knowledge. MSAT is at the crossroad of R&D and production. It is a multi-disciplinary function that provides expertise in process, manufacturing sciences, process modeling, statistical analysis, process validation and technology transfer.

The MSAT team in Sanofi Modulus, Singapore is seeking fixed-term support as MSAT Process Engineer interns to support Upstream processing (USP) and Downstream processing (DSP) experts in process validation activities and process material onboarding.

Main responsibilities

In this role, you will support MSAT process experts during the project startup phase and preparations for process validation, such as:

Draft protocols and reports for process validation and MSAT studies, such as mixing validation, bioburden hold studies and biochemical hold studies.
Draft technical documents such as protocols, reports, risk assessments and positioning papers to support shake-down runs and engineering runs.
Support MSAT-led activities in data collation and analyses, as well as sample management and data inputs.
Review user requirements in the raw materials and single use technology (SUT) qualification and onboarding process.
Create user requirement specifications for SUT materials.
Contribute to and review material specifications.

About You

Holds or is working to complete a scientific or engineering degree (or higher), preferably in Biotechnology, Biological Sciences, or Chemical Engineering.
Is data-driven, scientifically curious and an effective communicator.
Ideally has work (or internship) experience in a cGMP biopharmaceutical facility, and/or small- or pilot-scale hands-on experience with mammalian cell culture and purification techniques.

Sanofi Behaviors

Sanofi Behaviours such as Stretch, Take Action, Act for Patients and Customers and Think One Sanofi are required to be demonstrated in this position.

Pursue progress, discover extraordinary

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Key responsibilities:

Key requirements:

Company Description

Job Description

Qualifications

Additional Information

Physical Demands

Work Conditions

Responsibilities

Education & Experience Requirements

Personal Qualities & Physical Demands

Company Description

Job Description

Qualifications

Additional Information

Responsibilities

Required Qualifications

Preferred Qualifications

Company Description

Job Description

Qualifications

Additional Information

Purpose

Responsibilities

Knowledge, Skills & Experience

Why you?

Basic Qualifications:

Basic Qualifications:

Preferred Qualifications:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.

Company Description

Job Description

Qualifications

Additional Information

Purpose

Responsibilities

Knowledge, Skills & Experience

Responsibilities

Qualifications

Company Description

Job Description

Qualifications

Additional Information

Purpose

Responsibilities

Knowledge, Skills & Experience

The Position

Die Möglichkeit

Wer Du bist

Who we are

About the job

About you

Why choose us?

Pursue Progress. Discover Extraordinary.

Pursue progress, discover extraordinary

Basic Qualifications:

Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk

Managing individual and team performance.

Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

Implementing change initiatives and leading change.

Sustaining energy and well-being, building resilience in teams.

Continuously looking for opportunities to learn, build skills and share learning both internally and externally.

Developing people and building a talent pipeline.

Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.

Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.

Budgeting and forecasting, commercial and financial acumen.

Bachelor’s degree or above in engineering, manufacturing technology, pharmaceutical science or equivalent field.

Technical knowledge and familiarity with product development processes, specifically the evaluation of DDCs and/or medical devices and/or manufacturing processes.

Knowledge of sterile drug product primary pack & devices, qualification process.

Experience with Design History File (DHF) assembly, maintenance, and/or remediation

Strong project management, organizational, and time management skills. Proven ability to manage time effectively, prioritize tasks appropriately, and proactively communicate priorities and efforts with team members and supervisor.

Experience managing documents, databases, and using tracking tools.

Knowledge and understanding of Good Manufacturing Practice (GMP), Pharmacopeia and regulatory standards including EU MDR 2017/745, 21 CFR part 4, 820, 210/211, ISO 13485, ISO 14971, and/or IEC 60601.

Experience supporting regulatory audits.

Design control and risk management experience.

Flexibility to face rapidly changing requirements and reprioritize based on stakeholder input.

Ability to work in a matrix international organization.

Written and oral fluency in English, with strong verbal and written communication skills.

Competence with full MS Office Suite (Word, Excel, Outlook, PowerPoint).

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