Manager, Contamination Events & Sterility Assurance Support

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Key Responsibilities Investigation Impact Assessment – Internal Sites Support microbiological and aseptic process impact assessments for investigations at BMS internal manufacturing sites, including environmental monitoring (EM) excursions, bioburden failures, sterility test failures, and aseptic process deviations. Evaluate root cause analyses (RCA) and contribute to assessment of product, process, and patient impact under the guidance of senior scientists. Author and contribute to impact assessment documentation, deviation records, and CAPA review in compliance with BMS quality systems and regulatory standards. Support timely completion of impact assessments, tracking action items and CAPA effectiveness in collaboration with site Investigation Leads Assist in monitoring and trending of microbiological data (EM, utility monitoring, sterility testing) to identify potential contamination signals and systemic issues. Collaborate with site Microbiology, Quality, MS&T, Manufacturing, and Validation teams to gather data and support impact assessment activities. Support preparation for regulatory agency inspections and internal audits by organizing impact assessment documentation and providing technical input as needed. External Manufacturing ( ExM ) Support Assist senior MQSA team members in the review and assessment of sterility and microbiological investigation impact assessments submitted by ExM partners (CMOs/CDMOs). Provide technical input on ExM impact assessment quality and RCA adequacy, escalating gaps or risks to the Principal Scientist or Sr. Director. Support quality risk assessments at CMOs, contributing to periodic risk reviews of aseptic processing operations and contamination control programs. Support periodic trend reviews of ExM microbiological data and investigation metrics, contributing to risk-based oversight activities. Participate in remote or on-site technical interactions with ExM partners as needed, building knowledge of external site operations and capabilities. Aseptic Process Support Provide scientific support for aseptic processing activities including environmental monitoring program reviews, cleanroom classification, and gowning qualification. Contribute to contamination control strategy (CCS) development and maintenance activities in alignment with EU GMP Annex 1 (2022) and ICH Q9 principles. Support aseptic process change control reviews by providing microbiology and sterility assurance input on proposed changes to operations, equipment, or environments. Assist in the evaluation and implementation of cGMP improvements related to aseptic processing, sterility assurance, and environmental monitoring. Technical Contribution & Development Contribute to the development and maintenance of MQSA standard operating procedures (SOPs), guidance documents, and training materials. Stay current with evolving regulatory guidance (e.g., EU GMP Annex 1, FDA Aseptic Processing Guidance, USP chapters) and share learnings with the team. Participate in cross-functional project teams, working groups, and forums related to sterility assurance and microbiology. Actively develop technical expertise in aseptic manufacturing, contamination control, and investigation methodology through on-the-job experience and professional development. Qualifications & Experience Education Required: B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline. Experience Minimum 3 years (B.S.) or 1 year (M.S.) of experience in microbiology, sterility assurance, quality, or aseptic manufacturing within a GMP-regulated pharmaceutical or biopharmaceutical environment. Foundational knowledge of aseptic processing principles, environmental monitoring programs, and sterility testing (e.g., USP , ). Experience contributing to GMP impact assessments and deviation/CAPA documentation in a regulated manufacturing environment. Familiarity with applicable regulatory requirements including FDA 21 CFR Parts 210/211, EU GMP Annex 1, and USP microbiological chapters. Strong attention to detail, data integrity awareness, and technical writing ability for GMP documentation. Effective collaborator with the ability to work across functions and communicate clearly with both technical and quality stakeholders. Experience with environmental monitoring (EM) data trending and excursion investigation. Exposure to aseptic process simulations (media fills) and associated investigation activities. Familiarity with contamination control strategy (CCS) concepts and EU GMP Annex 1 (2022 revision). Experience supporting quality risk assessments at External Manufacturing partners from a microbiology or quality perspective. Proficiency with quality management syste