MSAT Drug Product Senior Scientist
About the role
We are seeking an experienced and hands-on candidate to join and strengthen our MSAT Drug Product team. In this position, the successful candidate will play a key role in supporting AAV Drug Product formulation and Good Manufacturing Practice (GMP) manufacturing activities.
The responsibilities of this role include working in close collaboration with teams from Research & Development (R&D), production, Quality Control (QC), and Quality Assurance (QA), as well as with external partners. The candidate will be expected to help define robust formulation and process strategies that ensure the quality and consistency of the drug product.
Additionally, the role involves providing support for process scale-up and process validation activities. This is critical for facilitating the transition of products to the late stages of the product life cycle. The candidate will also contribute scientific input on issues related to drug product manufacturability and stability, ensuring that processes remain efficient and compliant with regulatory standards.
Key Tasks
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Define and support product-centric formulation and drug product process strategies in collaboration with R&D, production, QC and external partners.
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Act as a scientific SME for formulation and drug product manufacturing to internal teams and external clients.
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Support Fill-Finish team in troubleshooting, supportive studies and process improvement initiatives.
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Contribute to scale up and transfer from development to commercial production (incl. gap analysis, process characterization, PPQ activities).
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Review and apply literature/patent findings to improve AAV stability and manufacturability.
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Design studies, analyze data, write technical protocols/reports, and present conclusions (internal and external).
Requirements
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PhD or Masters’s degree in pharmacy, biotechnology, biology, biomedical engineering, or similar with at least 3 years of experience in Fill-Finish, in MSAT or viral vectors manufacturing
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Practical knowledge of GMP and regulatory guidelines and standards is beneficial
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Experience with process characterization, validation activities (PPQ) and transfer/scale up is beneficial.
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Strong problem‑solving, documentation and communication skills.
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Ability to set priorities, meet deadlines and work collaboratively.
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Encourage a culture of innovation and learning by contributing ideas and continuous improvements.
Why join us?
This is a unique opportunity to apply your modeling expertise to real-world challenges in gene therapy manufacturing. You will contribute to innovative projects, develop your skills, and help shape the future of advanced therapies. If you are passionate about statistical and mathematical modeling and eager to make a difference, we encourage you to apply!
