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You will lead and inspire a team of approximately 10 scientists (a mix of Research Engineers/PhDs and Technicians) dedicated to the design, optimization, and scale-up of synthetic processes for future drug candidates. Operating at the interface between
You will lead the development and execution of global regulatory strategies in close collaboration with co-development partners and internal and external stakeholders. Acting as regulatory lead for complex projects, you will draw upon
Lead technology transfers and regulatory submissions while managing multiple programs in line with CMC objectives and timelines. Apply Best Product at Pivotal and Speed to the Clinic principles, prioritize resources across competing programs, and ensure
Provide QA support and expertise to iPSC cell culture, cell banking, cell differentiation in bioreactor and aseptic manufacturing activities; Maintain a strong QA presence on the shop floor and promote a proactive, right-first-time quality culture;
Support the Drug Linker Development Organization Head in the ramp up phase of the Accelerate Asset Development unit by defining and supporting the implementation of all critical business processes for drug linker projects; Manage the hiring process of the