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.

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