Director, ASAT Critical Reagent Operations

Bristol Myers Squibb • Devens, MA

4d • $184,550 - $245,995

About The Position

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. The 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 technical professionals and partners across Quality, Supply Chain, Procurement, Regulatory, and external organizations to ensure reagent availability, comparability, compliance, and sustainability throughout the product lifecycle.

As a recognized technical leader and subject matter expert, the Director drives network harmonization, innovation, risk management, and enterprise-wide initiatives that support reliable patient supply and commercial growth. The role provides strategic oversight for critical reagent testing programs, investigations, deviations, CAPAs, change controls, and risk assessments; leads inspection readiness and represents the organization during regulatory inspections and audits; and fosters accountability, inclusion, collaboration, innovation, and scientific excellence. The Director also coaches and mentors leaders and technical staff to strengthen organizational effectiveness and professional growth.

The position reports to the Executive Director of Analytical Sciences and Technology (ASAT), Cell Therapy.

Requirements

• Bachelor's degree in Biology, Chemistry, Biochemistry, Molecular Biology, Bioengineering, Pharmaceutical Sciences, or a related scientific discipline.
• 12+ years of relevant experience, or an equivalent combination of education and experience, in 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, 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.
• Success leading network-wide scientific, technical, and operational initiatives affecting 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 highly complex, cross-functional, and global initiatives.
• Ability to influence senior leadership and drive enterprise-wide decisions.
• Strong enterprise mindset and business acumen, balancing operational needs, regulatory requirements, and long-term business objectives.
• Exceptional leadership, influencing, and stakeholder management skills, including success driving alignment across Supplier Quality, Global Procurement, QC Operations, and other cross-functional organizations.
• Ability to identify emerging technologies, industry trends, and innovative solutions and translate them into business value and organizational capability.
• 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 engage effectively with senior leadership, regulatory agencies, external partners, and industry forums.

Nice To Haves

• Advanced degree (MS or PhD).
• Experience supporting regulatory inspections and global health authority interactions.

Responsibilities

• 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 the enterprise owner for critical reagent governance across the Cell Therapy network.
• Establish long-term plans for reagent availability, sustainability, and business continuity.
• Oversee the lifecycle management of commercial critical reagents, including qualification, implementation, monitoring, change management, retirement, and replacement.
• Lead reagent comparability assessments and bridging strategies 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, and 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 for 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.
• 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.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings.
• Flexible Time Off (FTO) for eligible U.S.-based exempt employees, subject to manager approval.
• 11 paid company holidays each year.
• For eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico: 160 hours of paid vacation annually for new hires, subject to manager approval, 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, 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 may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for additional discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Director