Sr. Director, Aseptic Operational Support
Bristol Myers Squibb EU Policy
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Benefits offered by this job
Job summary
Qualifications
- 15+ years in the pharmaceutical industry focusing on microbiology, sterility assurance, contamination control, or aseptic processing
- 8–10+ years in senior leadership with enterprise-level accountability for quality or regulatory strategy
- Experience across multiple manufacturing modalities (small molecule, biologics, cell or gene therapies)
- Strong understanding of global regulatory frameworks (FDA, EMA, ICH, USP) and experience with inspections
Responsibilities
- Govern aseptic operations, environmental monitoring, and microbial control programs enterprise-wide
- Lead Quality Council and EAC activities for sterility assurance and risk management
- Define thresholds for escalation of contamination events and systemic risks
- Establish enterprise-wide policies, standards, and procedures for aseptic control
- Set strategy and roadmaps for sterility assurance across sites
- Develop KPIs and monitoring to measure program effectiveness and compliance
- Lead trend detection, signal monitoring, and root-cause analyses across sites
- Provide guidance for regulatory inspections and technology transfers
Skills
Education
Job 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.
- Govern enterprise aseptic and microbial control practices, including the design and management of escalation pathways, cross-functional forums, and structured decision frameworks
- Provide executive-level leadership for Quality Council and EAC activities related to sterility assurance and contamination control
- Define and maintain clear thresholds for escalation of contamination events, systemic risks, and critical microbial control deviations across sterile and non-sterile manufacturing sites
- Establish and own enterprise-wide policies, standards, and procedures governing aseptic operations, environmental monitoring, and microbial control programs
- Strategy, Roadmap & Performance Monitoring
- Define the enterprise aseptic, microbial control, and sterility assurance roadmap — inclusive of short-term priorities and long-range capability-building strategies
- Establish enterprise KPIs and a comprehensive performance monitoring strategy to measure program effectiveness, site compliance, and continuous improvement outcomes
- Lead enterprise trend detection, signal monitoring, and recurring event analysis across both sterile and non-sterile manufacturing environments
- Translate performance data and risk signals into actionable strategies and executive-level insights
- Drive cross-site harmonization of aseptic and microbial control practices across the global manufacturing network
- Build, facilitate, and sustain a Community of Practice (CoP) for sterility assurance and contamination control, enabling knowledge sharing, peer learning, and best practice dissemination
- Lead enterprise knowledge management initiatives — capturing learnings from deviations, audits, and industry trends and converting them into prevention actions and training content
- Champion a culture of continuous improvement and scientific rigor across both sterile and non-sterile manufacturing communities
- Serve as the enterprise technical authority for all matters related to sterility assurance, contamination control, aseptic processing, and microbial risk management
- Provide aseptic and contamination control expertise in technology transfers, PPQ readiness and commercialization activities across internal and external manufacturing sites
- Lead governance and oversight of high-risk, systemic, or cross-site contamination events — including Subject Matter Expert (SME) impact assessments, root cause investigations, and CAPAs
- Provide authoritative technical guidance on sterile and non-sterile contamination events, ensuring scientifically sound and regulatory-aligned conclusions
- Represent BMS as the senior technical voice in regulatory inspections, agency interactions, and industry forums related to aseptic operations and microbial control
- Define enterprise environmental monitoring (EM) program requirements, including:
- Alert and action limit standards
- Sampling plan design and review
- Monitoring frequency standards
- Personnel sampling requirements
- Ensure EM program requirements are consistently applied across sterile manufacturing environments and extended appropriately to relevant non-sterile environments
- Lead periodic review and modernization of EM standards in alignment with evolving regulatory expectations and industry best practices (e.g., PDA, USP, EU GMP Annex 1)
- Monitor and trend enterprise CMO aseptic and microbial control performance indicators and risk signals; capture and disseminate learnings as enterprise-level prevention actions
- Provides technical input for CMO escalations, deviations, investigations, and technology transfers involving aseptic or microbial control considerations
- Conduct risk-tiered CMO assessments for aseptic practices and microbial control, establishing differentiated oversight models based on risk profile and performance history
- Design and implement standardized CMO oversight tools, dashboards, and decision trees to enable consistent and data-driven monitoring of aseptic and microbial control performance across the CM
- Govern and provide expert guidance on gowning qualification programs and gowning sequence standards across aseptic and controlled manufacturing operations
- Define optimal personnel, material, and waste flow strategies for aseptic and controlled manufacturing environments to minimize contamination risk
- Support facility design reviews and cleanroom classification initiatives, providing expert input on layout, pressure differentials, and contamination control by design
- Required: Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline
- 15+ years of progressive pharmaceutical industry experience in microbiology, sterility assurance, contamination control, or aseptic processing
- Minimum 8–10 years in senior leadership roles with enterprise-level accountability for quality, compliance, or regulatory strategy
- Deep experience working in manufacturing facilities across multiple manufacturing modalities, including small molecule, biologics, cell therapy, or gene therapy
- Demonstrated expertise in global regulatory frameworks (FDA 21 CFR Parts 210/211/600, EU GMP Annex 1, Part IV for Advanced Therapies, ICH Q9/Q10, USP //, PIC/S, and other applicable guidance)
- Proven experience leading or supporting regulatory inspections (FDA PAI/GMP, EMA, MHRA, or equivalent)
- Experience governing CMO/CDMO quality relationships and aseptic compliance requirements
- Track record of successfully leading enterprise-wide harmonization and change management programs
- Enterprise thinking: Ability to translate site-level data into network-wide strategy and risk management decisions
- Technical depth: Recognized internal and external authority in aseptic sciences, contamination control, and environmental monitoring
- Executive communication: Skilled at distilling complex technical content for senior leadership, regulatory agencies, and external partners
- Change leadership: Ability to influence without direct authority across a complex, matrixed global organization
- Data fluency: Proficiency in leveraging performance dashboards, trend analytics, and KPIs to drive decisions
- Collaboration: Strong cross-functional partnership skills across Quality, Operations, MS&T, Regulatory, and Supply Chain
- Advanced degree (M.S. or Ph.D.) in Microbiology or a related field
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.
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.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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