Manager, Contamination Events & Sterility Assurance Support

Role: Manager of Contamination Events & Sterility Assurance Support, overseeing microbiological impact assessments at Bristol Myers Squibb's manufacturing sites. Responsibilities include evaluating environmental monitoring excursions, bioburden failures, and process deviations; authoring impact assessments and deviation records; monitoring microbiological data for contamination trends; supporting regulatory inspections and internal audits; and providing scientific input for aseptic process support and contamination control strategies. Qualifications: B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or related field; minimum of 3 years (B.S.) or 1 year (M.S.) in microbiology, sterility assurance, or aseptic manufacturing within GMP environments; knowledge of USP, EU GMP Annex 1, and FDA regulations; experience with environmental monitoring, GMP impact assessments, and microbiological investigations; strong data integrity, technical writing, and cross-functional collaboration skills. Preferred: M.S. in related disciplines. High-Value: expertise in aseptic processing, contamination control, microbiology, regulatory compliance (EU GMP, FDA), and GMP documentation; support for external manufacturing risk assessments; up to 25% travel; role supports both internal and external manufacturing sites, including CMO oversight. Work setup: not specified.