Sr. Director, Aseptic Operational Support

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. Key Responsibilities Enterprise Governance & Leadership 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 Cross-Site Harmonization & Knowledge Management 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 Technical Authority & Contamination Event Leadership 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 Environmental Monitoring Program Ownership 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) CMO Oversight — Selection Process, Qualification & Ongoing Governance 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 Gowning, Personnel Flow & Aseptic Facility Design Guidance 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 Qualifications & Experience Education Required: Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline Experience 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 Skills & Competencies 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 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