Overview
In this MSAT-focused role, you lead complex biologics programs, guiding transfer and scale-up of bioprocesses into GMP manufacturing. You will partner with operations, quality and engineering to ensure robust, scalable processes that meet regulatory expectations. The position sits at the interface of development and manufacturing, offering hands-on technical leadership and cross-functional collaboration. You will shape transfer strategies and drive impact on commercial production, joining an established pharma-focused team.
Responsibilities
- Lead process transfer and scale-up into GMP manufacturing as the biologics SME
- Prepare and review technical documentation (process descriptions, change controls, risk assessments)
- Plan and oversee experiments and pilot-scale studies with data interpretation and reporting
- Ensure processes are robust, scalable, and manufacturing-ready
- Collaborate cross-functionally with operations, quality, engineering, and supply chain
- Support investigations including deviations, root cause analysis, and impact assessments
Key requirements
- Degree (or higher) in a scientific or engineering discipline with strong recent industry experience
- Proven bioprocessing expertise (upstream and/or downstream)
- Experience with process transfer, MSAT, or manufacturing support environments
- Experience in biologics or advanced therapeutics development
- GMP experience, ideally supporting manufacturing or scale-up
- Ability to lead or contribute to complex technical projects
- Strong problem-solving and data interpretation skills
- Excellent communication and cross-disciplinary collaboration
- Mentoring or informal leadership experience
- strong communication
- cross-functional collaboration
- problem-solving
- bioprocessing (upstream/downstream)
- process transfer
- MSAT experience
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