Sr. Manager, Contamination Events and Investigations

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 complex microbiological and sterility assurance investigations at BMS internal manufacturing sites, including environmental monitoring (EM) excursions, sterility test failures, and process-related contamination events Serve as the MQSA SME providing microbiological and aseptic process impact assessments for investigations. Apply advanced microbiology, contamination control, and aseptic processing knowledge to critically evaluate root cause analyses (RCA) and assess product, process, and patient impact. Review and provide formal sign-off on impact assessment sections of investigation reports, CAPA records, and deviation documentation, ensuring conclusions are scientifically sound and aligned with regulatory expectations (FDA, EMA, ICH). Partner with site Investigation Leads to ensure investigation scope, RCA depth, and CAPA effectiveness adequately address microbiological and aseptic process risk. Rapid Response & Triage: Lead immediate containment and triage efforts for sterility breaches, including leaks, mold recoveries, and contamination events across a broad network of stakeholders. Track and trend impact assessment outcomes across sites to identify systemic issues and emerging risk patterns requiring escalation. Support preparation for regulatory agency inspections and audits related to impact assessment findings and sterility assurance. External Manufacturing (ExM) Support Serve as MQSA technical liaison for ExM partners on sterility and microbiological investigations, providing SME guidance to ensure investigation quality aligns with BMS standards. Partner with site the MS&T Virtual plant teams (VPTs) lead to ensure investigation scope, RCA depth, and CAPA effectiveness adequately address microbiological and aseptic process risk. Critically review impact assessments and investigation reports submitted by ExM partners, providing constructive feedback to drive adequate risk evaluation and CAPA responses. Support quality risk assessments at CMOs, including periodic risk reviews of aseptic processing operations, contamination control programs, and microbiological data trends. Design and implement standardized CMO oversight tools, dashboards, and decision trees for aseptic and microbial control performance Participate in remote and on-site technical reviews with contract manufacturing organizations (CMOs) as needed during escalated events or regulatory commitments. Participation in site assessments/vendor selection for CMOs/vendor with Procurement, MS&T, Quality, and other business functions. Technical SME on Quality Audit team for External manufacturing sites. Aseptic Process Support Provide technical expertise in aseptic processing principles, including barrier technology (RABS/isolators), cleanroom design, gowning programs, and aseptic technique qualification. Support aseptic process simulations (media fills) – planning, review, and failure investigation – and provide technical input on process validation and revalidation activities. Contribute to contamination control strategies (CCS) development and maintenance per Annex 1 (2022) requirements across internal and ExM sites. Assess and advise on aseptic process change controls, providing risk-based SME review of proposed changes to aseptic processing operations, equipment, and environments. Support implementation of current Good Manufacturing Practice (cGMP) improvements and regulatory guidance interpretation related to aseptic processing and sterility assurance. Interface with the Biologics Drug substance /Drug Product MS&T and/or Cell Therapy Tech Ops group and product specific technical teams to consult on microbial sampling during technology transfers and qualification activities. Technical input, authoring (when applicable), and approval of CMC documents for process validation P.3.5 sections. Support CMC queries and resolution with Global Health Authorities, and support plant inspections. Technical Leadership & Knowledge Sharing Act as a technical resource and mentor for site-level microbiologists and quality professionals, elevating investigation and aseptic process competency across the network. Contribute to the development and maintenance of global MQSA standards, SOPs, guidance documents, and training materials. Monitor evolving industry trends, regulatory updates, and scientific literature to ensure BMS practices remain current and ahead of compliance risk. Represent MQSA in cross-functional teams, steering committees, and governance forums related to sterility and microbiology Interface with industry consortiums such as BPOG, ISPE, PDA to maintain a view of the current trends and best practices for aseptic processing. Qualifications & Experience Education Required: B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline. Experience Minimum 8 years of direct experience in microbiology, sterility assurance, or aseptic manufacturing within a GMP-regulated pharmaceutical or biopharmaceutical environment Deep expertise in aseptic processing operations, environmental monitoring programs, and sterility test methodologies: experience i either biologics and/or cell therapy, or gene therapy. Demonstrated experience leading complex microbiological investigations, RCA methods, and CAPA development. Strong technical writing skills with experience authoring regulatory-grade investigation reports and deviation records. Working knowledge of applicable regulatory frameworks including FDA 21 CFR Parts 210/211/600, EU GMP Annex 1, ICH Q9/Q10, and USP chapters (e.g., , ). Ability to work effectively in a matrix organization, collaborating across functions and geographies without direct authority. Experience supporting or overseeing External Manufacturing partners from a microbiology and sterility assurance perspective. Familiarity with contamination control strategy (CCS) development aligned with EU GMP Annex 1 (2022 revision). Experience with isolator and/or RABS barrier technology in aseptic manufacturing. Participation in regulatory agency inspections (FDA, MHRA, EMA) as a SME or technical reviewer. Skills & Competencies Enterprise thinking: Ability to translate site-level data into network-wide strategy and risk management decisions Technical depth: Recognized internal and external authority in aseptic sciences, contamination control, and environmental monitoring Executive communication: Skilled at distilling comp