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Posted: 10/21/2026Director, ASAT Critical Reagent Operations
Bristol Myers SquibbCore Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in critical reagent lifecycle management, including qualification, characterization, and supplier oversight within GMP-regulated environments. Proven ability to lead cross-functional initiatives and influence enterprise-wide decisions while ensuring regulatory compliance and operational excellence.
Highest-signal resume keywords
Critical Reagent Lifecycle ManagementGMP-Regulated EnvironmentsRegulatory ComplianceLeadership ExperienceRisk-Based Strategies
About the role
Key responsibilities & impact- Define and execute the network strategy, governance model, and operating framework for critical reagents supporting commercial Cell Therapy manufacturing and testing
- Establish standards for critical reagent qualification, characterization, performance monitoring, lifecycle management, and replacement strategies
- Serve as enterprise owner for critical reagent governance across the Cell Therapy network
- Establish long-term plans for reagent availability, sustainability, and business continuity
- Oversee commercial critical reagent lifecycle management, including qualification, implementation, monitoring, change management, retirement, and replacement
- Lead reagent comparability assessments and bridging strategies supporting manufacturing continuity
- Establish proactive reagent refresh and replacement strategies to mitigate supply risks
- Drive network harmonization of reagent specifications, testing requirements, and performance monitoring programs
- Govern critical reagent supplier qualification, performance monitoring, and risk assessments
- Lead technical evaluations for supplier changes, reagent discontinuations, and supply interruptions
- Develop mitigation strategies for sole-source reagents and high-risk materials
- Support new commercial manufacturing technologies and product launches
- Evaluate emerging technologies and next-generation reagent platforms
- Improve reagent robustness, simplify testing approaches, and increase supply resilience
- Translate industry trends and scientific advances into future-state reagent strategies
- Serve as ASAT representative and technical authority for critical reagent strategies and testing programs
- Act as subject matter expert for Cell Therapy critical reagents
- Drive scientific innovation and continuous improvement initiatives
- Provide strategic oversight of investigations, deviations, CAPAs, change controls, and risk assessments
- Lead inspection readiness activities and represent the organization during regulatory inspections and audits
- Coach and mentor leaders and technical staff
- Report to the Executive Director of Analytical Sciences and Technology (ASAT), Cell Therapy
Requirements
What you’ll need- Bachelor's degree in Biology, Chemistry, Biochemistry, Molecular Biology, Bioengineering, Pharmaceutical Sciences, or a related scientific discipline required; advanced degree (MS or PhD) preferred
- 12+ years of relevant experience, or equivalent combination of education and experience, within biotechnology, pharmaceuticals, cell therapy, gene therapy, or biologics manufacturing environments
- 6+ years of leadership experience managing scientific, technical, and/or operational teams
- Expertise in critical reagent lifecycle management, qualification, characterization, supplier oversight, and comparability strategies within GMP-regulated environments
- Strong knowledge of commercial manufacturing processes, QC testing, product quality, process performance, and regulatory compliance
- Experience supporting reagent strategy, reagent replacement programs, method lifecycle management, and product lifecycle activities
- Success leading network-wide scientific, technical, and operational initiatives impacting commercial manufacturing and QC operations
- Experience developing risk-based strategies for supply continuity, reagent sustainability, and business continuity planning
- Strong understanding of regulatory expectations related to critical reagents, analytical methods, comparability, and commercial product lifecycle management
- Success leading complex, cross-functional, and global initiatives
- Ability to influence senior leadership and drive enterprise-wide decisions
- Experience supporting regulatory inspections and global health authority interactions preferred
- Strong enterprise mindset and business acumen
- Exceptional leadership, influencing, and stakeholder management skills
- Ability to identify emerging technologies, industry trends, and innovative solutions and translate them into business value
- Ability to build, develop, and lead high-performing teams through coaching, mentoring, succession planning, and organizational development
- Excellent communication and executive presence
Benefits
Comp & perks- Comprehensive wellbeing support, retirement and financial protection benefits
- Medical, dental, vision, life and disability insurance offerings
- Flexible Time Off (FTO) for U.S.-based exempt employees
- 11 paid company holidays annually
- 160 hours of paid vacation annually for eligible new hires
- 3 optional holidays for eligible employees
- Paid sick leave, subject to eligibility
- 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
- Additional discretionary incentive cash
- Stock opportunities
- Workplace accommodations/adjustments and ongoing support for people with disabilities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Critical Reagent QualificationPerformance MonitoringChange ManagementReagent Comparability AssessmentsLifecycle ManagementCommercial Manufacturing ProcessesQC TestingAnalytical MethodsBusiness Continuity PlanningEmerging Technologies Evaluation
Soft Skills
LeadershipInfluencingStakeholder ManagementCoachingCommunication
Industry Keywords
Cell TherapyBiotechnologyPharmaceuticalsGene TherapyBiologics ManufacturingRegulatory InspectionsCAPAsChange ControlsSupply ContinuitySustainability