Quality
Senior Manager, Team Lead Upstream Process Science and Validation
Kort om jobbet
Employment type: FULLTIME. Requisition: 3132396. Senior Manager, Team Lead Upstream Process Science & Validation Do you want to lead a highly skilled upstream team and help shape how Process Science & Validation (PSV) support Lundbeck’s biologics portfolio?
Join us as Senior Manager and combine people leadership with scientific direction in a CMO-based manufacturing model, helping ensure robust upstream processes from technology transfer through process characterization and validation, PPQ and commercial readiness.
Your new role As Senior Manager and Team Lead for Upstream Process Science & Validation, you will lead and develop a team of Upstream Subject Matter Experts within PSV in CMC Biologics. Lundbeck's biologics manufacturing is outsourced to external CMOs.
You will set direction, prioritize resources and ensure high-quality delivery across portfolio projects in close collaboration with Downstream PSV, Process Development, CMC Project Managers, Quality, Regulatory CMC, Analytical Development, and External Manufacturing.
You will guide and challenge upstream strategies, support technical decision-making and ensure robust CMC input to regulatory submissions and health authority interactions. As part of the PSV management team, you will also contribute to strengthening capabilities and ways of working across PSV1 …
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