Sr. Director, Aseptic Operational Support

Bristol Myers Squibb•Devens, MA

1d•$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
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 <797>/<1072>/<71>, 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

Nice To Haves

Advanced degree (M.S. or Ph.D.) in Microbiology or a related field

Responsibilities

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
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

Benefits

wellbeing support
retirement and financial protection benefits
insurance offerings (medical, dental, vision, life and disability)
Flexible Time Off (FTO)
11 paid company holidays
160 hours of paid vacation annually
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