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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;
Provide clearly defined Quality expectations and a Quality strategy for the assigned program(s) within the BioNTech product portfolio; Critically evaluate new products and processes with respect to Quality and compliance requirements. Work with
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
Develop Manufacturing Industrial Strategic Supply Plans for Drug Products throughout their lifecycle, aligned with the broader supply-network strategy; Build and oversee the strategic industrial project portfolio covering launches, lifecycle management,
Ensuring the sterility of injectable products through robust contamination control and sterility assurance strategies. This role extends beyond microbiological testing to encompass comprehensive oversight of aseptic manufacturing