Manager, Contamination Events & Sterility Assurance Support

Role: Manager of Contamination Events & Sterility Assurance Support at Bristol Myers Squibb, focusing on microbiological impact assessments, contamination investigations, and aseptic process support within GMP-regulated biopharma manufacturing. Responsibilities: evaluate microbiological deviations (EM excursions, bioburden, sterility failures), contribute to root cause analyses, author impact documentation, monitor microbiological data trends, support external manufacturing microbiology assessments, and assist in aseptic processing activities aligned with EU GMP Annex 1 and ICH Q9. Collaborate with microbiology, quality, manufacturing, and validation teams; prepare for audits and inspections; contribute to contamination control strategies and GMP compliance. Requirements: B.S. in Microbiology, Pharmaceutical Sciences, Biology, or related field; minimum 3 years microbiology or sterile manufacturing experience in pharma/biotech GMP environment; knowledge of environmental monitoring, sterility testing, and regulatory standards (FDA, EU GMP, USP); strong data analysis, documentation, and cross-functional communication skills. Preferred: M.S. degree; experience with contamination risk assessments, trend analysis, and microbiological investigations, including media fills and external partner assessments. High-Value: expertise in aseptic processing, contamination control, microbiological trend monitoring, and GMP documentation; up to 25% travel; support for environmental monitoring programs and risk management in sterile manufacturing.