Sr. Director, Aseptic Process & Design

Bristol Myers Squibb • Devens, MA

7d • $218,880 - $283,796 • Hybrid

About The Position

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.

Requirements

• Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline
• 12+ years of progressive experience in pharmaceutical manufacturing, quality, sterility assurance, or microbiology within a regulated GMP environment
• 7+ years of senior/leadership experience with direct accountability for sterile manufacture
• Demonstrated expertise in aseptic process design, environmental monitoring, contamination control strategy, and regulatory submissions/inspections
• Proven track record leading cross-functional teams across global, matrixed organizations
• Deep knowledge of EU GMP Annex 1, FDA Aseptic Processing Guidance, ICH Q9/Q10/Q11, USP <1116>, <797>, and other relevant compendia
• Proficiency in risk management tools (FMEA, fault tree analysis, contamination control risk assessments)
• Strong command of APS/media fill design, smoke visualization studies, sterilization science, and WFI/PW/utility microbiology
• Exceptional scientific communication skills — able to translate complex microbiological risk into clear, actionable guidance for diverse audiences including senior leadership and regulators
• Strong regulatory inspection acumen with demonstrated experience in health authority-facing roles
• Collaborative, influential leadership style with the ability to drive alignment across QA, MS&T, Operations, Engineering, and External Partners
• Strategic thinker with the ability to scale enterprise standards across a diverse global network
• Willingness to travel domestically and internationally (estimated 25–35%) to manufacturing sites and third-party partners

Nice To Haves

• Experience with Single-Use Technologies (SUT), biologics, or complex drug product manufacturing strongly preferred
• Familiarity with hygienic engineering standards (ASME BPE, EHEDG)
• Advanced degree (M.S. or Ph.D.) in Microbiology or a related field

Responsibilities

• 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
• 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
• 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
• 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
• 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
• 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
• 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

Benefits

• wellbeing support
• retirement and financial protection benefits
• insurance offerings (medical, dental, vision, life and disability)
• Flexible Time Off (FTO)
• 11 paid company holidays each year
• 160 hours of paid vacation annually for new hires
• 3 optional holidays
• paid sick leave
• up to two paid volunteer days per year
• summer hours flexibility
• leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
• annual Global Shutdown between Christmas Day and New Year's Day

What This Job Offers

• Job Type: Full-time
• Career Level: Director