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 andmaintaintheenterprise 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 thatimpactsterility 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
• Provideexpertiseand author standards for sterilization of Single-Use Technologies (SUT) and consumables, including extractables/leachablesconsiderations 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 controlexpertiseto 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 reviewsof 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…