Director, ASAT Critical Reagent Operations
Bristol Myers Squibb · Devens, Massachusetts, United States
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.
Position Summary
The Director, Analytical Science and Technology Cell Therapy Critical Reagent provides strategic and technical leadership for the commercial critical reagent program across the Cell Therapy manufacturing network. This role is accountable for the global strategy, governance, lifecycle management, testing oversight, and supply continuity of critical reagents supporting GMP Quality Control operations.
The Director leads a team of technical professionals and partners across Quality, Supply Chain, Procurement, Regulatory, and External Partners to ensure availability, comparability, compliance, and sustainability throughout the product lifecycle. As a recognized technical leader, the Director drives network harmonization, innovation, risk management, and enterprise-wide initiatives that support reliable patient supply and commercial growth.
Duties Responsibilities
- Define and execute the network strategy, governance model, and operation framework 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 the enterprise owner for critical reagent governance across the Cell Therapy network.
- Establish long-term plans to ensure reagent availability, sustainability, and business continuity
- Provide oversight of the lifecycle management of commercial critical reagents including qualification, implementation, monitoring, change management, retirement, and replacement.
- Lead reagent comparability assessments and bridging strategies required to support manufacturing continuity.
- Establish proactive reagent refresh and replacement strategies to mitigate supply risks.
- Drive network harmonization of critical reagent specifications, testing requirements, and performance monitoring programs.
- Provide governance for 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 implementation of new commercial manufacturing technologies and product launches.
- Evaluate emerging technologies and next-generation reagent platforms to strengthen manufacturing reliability and scalability.
- Identify opportunities to improve reagent robustness, simplify testing approaches, and increase supply resilience.
- Translate industry trends and scientific advances into future-state reagent strategies.
- Develop and implement long-term strategies that ensure critical reagent quality, supply reliability, compliance, and operational scalability.
- Serve as the ASAT representative and technical authority for critical reagent strategies and testing programs across the Cell Therapy network.
- Serve as a recognized subject matter expert for Critical Reagent for Cell Therapy.
- Drive scientific innovation and continuous improvement initiatives that advance testing capabilities, efficiency, and quality.
- Provide strategic oversight of investigations, deviations, CAPAs, change controls, and risk assessments affecting critical reagent testing programs.
- Lead inspection readiness activities related to critical reagents and represent the organization during regulatory inspections and audits.
- Foster a culture of accountability, inclusion, collaboration, innovation, and scientific excellence.
- Coach and mentor leaders and technical staff to strengthen organizational effectiveness and professional growth.
Reporting Relationship
This position will report to the Executive Director of Analytical Sciences and Technology (ASAT), Cell Therapy.
Qualifications
- 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.
- Demonstrated 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 and the impact of critical reagents on product quality, process performance, and regulatory compliance.
- Experience supporting reagent strategy, reagent replacement programs, method lifecycle management, and product lifecycle activities.
- Demonstrated 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.
- Demonstrated success leading highly complex, cross-functional, and global initiatives.
- Proven 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 with the ability to make decisions that balance operational needs, regulatory requirements, and long-term business objectives.
- Exceptional leadership, influencing, and stakeholder management skills with demonstrated success driving alignment across Supplier Quality, Global Procurement, and QC Operations, and other cross-functional organizations.
- Demonstrated ability to identify emerging technologies, industry trends, and innovative solutions and translate them into business value and organizational capability.
- Proven ability to build, develop, and lead high-performing teams through coaching, mentoring, succession planning, and organizational development.
- Excellent communication and executive presence with the ability to effectively engage in senior leadership, regulatory agencies, external partners, and industry forums.
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: $197,470 - $239,290
Seattle - WA: $203,010 - $245,995
Summit West - NJ - US: $184,550 - $223,634
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 ou