Director of Sterility Assurance

Role: Director of Sterility Assurance overseeing contamination control and aseptic processing for autologous cell therapy manufacturing supporting clinical and commercial programs. Responsibilities: develop and govern contamination control strategies aligned with GMP and regulatory standards, ensure environmental monitoring and cleanroom oversight, lead validation and media fill strategies, support regulatory inspection readiness, and drive investigations and CAPA processes. Collaborate with cross-functional teams including Manufacturing, Quality, Microbiology, and Regulatory Affairs; support BLA readiness and process validation activities. Lead and develop sterility assurance teams, fostering a proactive contamination-control culture. Requirements: Bachelor's in Microbiology, Biological Sciences, Engineering, or related field; 12+ years in sterile biologics, cell therapy, or aseptic pharma manufacturing with experience supporting late-stage clinical or commercial operations, including regulatory inspections. Deep expertise in aseptic processing, contamination control, environmental monitoring, and media fills; preferred experience with autologous workflows, cryopreservation, rapid sterility methods, and decentralized manufacturing models. High-value specifics: autologous cell therapy, GMP compliance, regulatory inspection experience, BLA support, process validation, environmental and contamination control, open manipulations, chain-of-identity/custody. Leadership: strategic thinker, strong communicator, capable of influencing cross-functional teams, building inspection-ready environments, and fostering a high-performance culture. Work setup: Not specified.