Director, ASAT Critical Reagent Operations
Bristol Myers Squibb
This listing was originally posted on Bristol Myers Squibb's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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Upgrade to Pro — $25/moAt 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:
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 our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including 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 also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.comwith the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
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