B

Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Director, ASAT Critical Reagent Operations

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A bachelor's degree in Biology, Chemistry, Biochemistry, Molecular Biology, Bioengineering, Pharmaceutical Sciences, or a related scientific discipline is required; an advanced degree (MS or PhD) is preferred.
  • At least 12 years of relevant experience, or an equivalent combination of education and experience, within biotechnology, pharmaceuticals, cell therapy, gene therapy, or biologics manufacturing environments.
  • At least 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.
  • Strong enterprise mindset and business acumen to make decisions balancing 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, 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 to engage senior leadership, regulatory agencies, external partners, and industry forums.

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 to ensure reagent availability, sustainability, and business continuity.
  • Oversee 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 reagents for Cell Therapy.
  • Drive scientific innovation and continuous improvement initiatives that advance testing capabilities, efficiency, and quality.
  • Provide strategic oversight of investigations, deviations, corrective and preventive actions (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.

Desired Qualifications

  • Experience supporting regulatory inspections and global health authority interactions.

About the Company

Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Bristol Myers Squibb discovers, develops and sells prescription medicines for serious illnesses, including cancer, blood disorders, immune diseases and heart disease, for patients treated by doctors and hospitals around the world. Its best-known drug is Opdivo, an immunotherapy that helps the body's own immune system find and attack many kinds of cancer. Researchers develop drug candidates in its labs or bring them in through acquisitions and partnerships, then test them in clinical trials to win regulatory approval. The company makes and markets the approved medicines and earns its revenue from sales of patent-protected drugs. Its roots go back to a business founded in 1887, and it is based in Lawrence Township, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Lawrence Township, NJ
Founded
1887

Recently Posted Jobs

Explore more opportunities at Bristol Myers Squibb

See more jobs