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.