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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;
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