Director, ASAT Critical Reagent Operations

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.

Duties and Responsibilities

• Define and execute the network strategy, governance model, and operation 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.
• 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.
• 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.

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 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.
• Exceptional leadership, influencing, and stakeholder management skills.
• Demonstrated ability to identify emerging technologies, industry trends, and innovative solutions and translate them into business value.
• Proven ability to build, develop, and lead high-performing teams through coaching, mentoring, succession planning, and organizational development.
• Excellent communication and executive presence.

Reporting Relationship

This position will report to the Executive Director of Analytical Sciences and Technology (ASAT), Cell Therapy.