Sr. Manager, Contamination Events and Investigations

Role: Senior Manager overseeing microbiological investigations and sterility assurance within Bristol Myers Squibb's manufacturing sites. Primary objectives include evaluating complex microbiological events (e.g., EM excursions, contamination), serving as the MQSA SME, and ensuring investigations meet regulatory standards. Responsibilities encompass leading impact assessments, reviewing investigation reports, partnering with internal and external manufacturing teams, supporting contamination control strategies, and contributing to regulatory inspections. The role also provides technical leadership in aseptic processing (barrier technologies, media fills, process validation), developing global standards, and mentoring microbiologists. Requirements: B.S. in Microbiology, Pharmaceutical Sciences, or related field; at least 8 years' GMP-regulated microbiology or sterility assurance experience, with expertise in biologics, cell therapy, or gene therapy aseptic processes. Strong technical writing, regulatory knowledge (FDA, EMA, ICH), and experience supporting manufacturing and external partners are essential. Preferred: M.S. degree. Skills include cross-functional collaboration, industry trend awareness, data analytics, and influence without authority. The position involves up to 25% travel and operates in a hybrid setting.