Sr. Director, Aseptic Process & Design
Description
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: Bachelor's degree in Microbiology , Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline
Experience
-
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
-
Experience with Single-Use Technologies (SUT), biologics, or complex drug product manufacturing strongly preferred
-
P roven track record leading cross-functional teams across global, matrixed organizations
Technical Expertise
-
Deep knowledge of EU GMP Annex 1, FDA Aseptic Processing Guidance, ICH Q9/Q10/Q11, USP , , 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
-
Familiarity with hygienic engineering standards (ASME BPE, EHEDG)
Leadership & Competencies
-
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
##
Preferred
-
Advanced degree (M.S. or Ph.D.) in Microbiology or a related field
#LI-Hybrid
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:
Devens - MA - US: $234,200 - $283,796
Madison - Giralda - NJ - US: $218,880 - $265,235
New Brunswick - NJ - US: $218,880 - $265,235
Princeton - NJ - US: $218,880 - $265,235
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits
Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-base