Sr. Director, Aseptic Process & Design

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 Enterprise Risk Framework & Taxonomy Define and maintain the enterprise sterility and microbial failure mode library, including risk classification taxonomy, contamination event typology, and risk-based sampling strategies Establish and own the enterprise-wide contamination control strategy (CCS) aligned with current regulatory expectations (EU Annex 1, FDA Aseptic Processing Guidance, ICH Q9/Q10) Develop and standardize risk assessment methodologies and tools used across global manufacturing sites Risk Assessment Governance & Quality Oversight Perform Global Microbial risk assessments of the internal sites and help build action plans with the sites to remediate risk. Provide authoritative review and sign-off on quality decisions that impact sterility assurance across the BMS network Serve as the enterprise escalation point for complex microbial and contamination-related quality events around Facilities, Equipment and Utilities Technical Authorship & Regulatory Inspection Support Author technical Business Technical Assessments (BTAs) and develop robust investigation and inspection-ready materials in support of systemic microbiological issues Serve as a key technical resource during regulatory inspections (FDA, EMA, PMDA, and others), providing expert testimony and documentation on aseptic process and microbial control matters Lead or support CAPA development and effectiveness monitoring for systemic contamination trends around Facilities, Equipment, and Utilities Aseptic Process Simulation (APS) & Media Fill Governance Define and govern the enterprise APS/media fill strategy, including program design, intervention criteria, acceptance expectations, and performance governance. Partnering with aseptic teams at the sites. Oversee the enterprise smoke study program, including design, execution standards, and review of outcomes to confirm airflow behavior in critical zones Establish qualification and requalification frameworks for aseptic filling operations Manufacturing Process & Equipment Design Standards Define manufacturing process and equipment design standards for sterilization and microbial control, including terminal sterilization, filtration sterilization, and SIP/CIP processes Provide expertise and author standards for sterilization of Single-Use Technologies (SUT) and consumables, including extractables/ leachables considerations and biocompatibility risk assessments Provide hygienic equipment design leadership to Quality, Engineering, and MS&T teams, ensuring robust contamination control by design Provide aseptic process and contamination control expertise to support Internal & External technology transfers Site Microbial Assessment Ownership Own and coordinate the microbial assessment of internal manufacturing sites, ensuring consistent application of enterprise standards and identification of systemic risk areas Conduct hygienic practice reviews of production environments and quality control test laboratories Drive continuous improvement initiatives based on environmental monitoring trend data, contamination investigation findings, and industry benchmark intelligence By-Design Oversight for Changes & Capital Projects Provide aseptic and microbial control by-design oversight for facility, utility, equipment, and process changes — for both sterile and non-sterile manufacturing sites Provide subject matter expertise at external manufacturers when investing in new technologies Engage at the design review stage of capital projects, cleanroom construction/renovation, and major equipment installations to embed contamination control principles from inception Accountable for reviewing and approving change controls with microbial or sterility assurance impact during design or critical changes in a facility Drive innovation in aseptic processing technologies including advanced barrier systems, automation and digital/AI enabled environmental monitoring and trend analytics Qualifications & Experience Education Required: <sp