Senior Manager, Internal Contamination Events & Investigations

Role: Senior Manager overseeing microbiological and sterility assurance investigations at BMS manufacturing sites, with a focus on contamination events, impact assessments, and regulatory compliance. Responsibilities include leading complex microbiological investigations, evaluating root causes, reviewing impact assessments, and supporting regulatory audits. The role also involves acting as a technical liaison for external manufacturing partners, reviewing investigation reports, and developing contamination control strategies aligned with EU GMP Annex 1. Additionally, the position provides technical expertise in aseptic processing, supports process validation, and mentors site microbiologists. It requires integration with cross-functional teams across Quality, Operations, and MS&T, and participation in site assessments and vendor selection. The position emphasizes advancing microbiology, contamination control, and aseptic techniques, ensuring compliance with FDA, EMA, and ICH regulations, and contributing to global standards and knowledge sharing. Location is flexible with up to 25% travel. Qualifications include a B.S. in Microbiology or a related science, with at least 8 years of GMP-regulated microbiology or sterile manufacturing experience, particularly in biologics, cell therapy, or gene therapy. Deep expertise in aseptic operations, environmental monitoring, and regulatory interactions is essential. Preferred qualifications include an M.S. and experience with RABS/bARRIER technology, regulatory inspections, and contamination control strategies. The role requires strong technical, leadership, and collaboration skills within a global, matrix organization.