Senior Scientist, Manufacturing Science (12-Months Temporary Position)

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

We are seeking an experienced and motivated Senior Scientist for our Manufacturing Science Team to join a dedicated group of scientists. The successful candidate will support manufacturing processes and continuous improvement projects for complex biotechnological products, ensuring operational efficiency, regulatory compliance, and product quality.

About The Team/Department

The Manufacturing Science Team is part of the newly established Process Science and Technology Department. The main purpose of the department is to support new business opportunities, evaluate new technologies and provide scientific support to operations, of which the operational support aspect is the primary function of the Manufacturing Science team.

• About the Role
• This role requires advanced technical problem-solving skills and a passion for bringing lifesaving products to patients.

Your Primary Tasks Will Include…

• Process owner for upstream processes, accountable for process performance, robustness, and lifecycle management.
• Lead technical authorship and review of GMP documents and process flow descriptions.
• Evaluate and implement process changes and change controls, including drafting and assessing change assessments to ensure compliance.
• Support deviation investigations and change control processes, in collaboration with the team.
• Serving as a subject matter expert (SME) in technical discussions and representing the Manufacturing Science team in client project teams.
• Support product life cycle changes, including driving the execution of long-term process improvements.
• Participate in internal audits, regulatory inspections, and quality reviews as an upstream subject matter expert (SME).
• Support additional tasks and cross-functional needs as assigned by management

Your Qualifications…

• MSc in Biotechnology, Biochemistry, Bioprocess, or a related field, with 5+ years of relevant experience in the pharmaceutical industry.
• PhD in Biotechnology, Biochemistry, Biology, Bioprocess, or a related field, with 2+ years of relevant experience in the pharmaceutical industry.
• Extensive experience and a solid understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g., ICH Q7A, 21 CFR Part 211, etc.).
• Proven experience in writing, reviewing, and approving technical documentation.
• Expertise in microbial and mammalian expression systems/ cell physiology.
• Expert in upstream bioprocess strategies including batch, fed-batch, and perfusion (e.g., ATF, TFF), with a strong understanding of their impact on cell growth, productivity, and product quality.
• Demonstrated ability to communicate and interface extensively with internal and external clients.
• Strong ability to coordinate multi-departmental tasks and deliverables.
• Proven experience managing multiple projects simultaneously.
• Demonstrated ability to build effective working relationships across departments to support new processes and products.
• Experience in providing technical training and sparring.

Application

• Please submit your CV and a short motivation letter. We encourage all qualified candidates to apply, even if you don’t meet every listed requirement. 
• Applications are only accepted through our recruitment system. We review CVs and conduct interviews on an ongoing basis, and the job posting will be closed once the position has been filled.   

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.