Associate Director / Director, Drug Product Lifecycle Management

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary

The Associate Director / Director of Drug Product Lifecycle Management within Cell Therapy Technical Operations (CTTO) leads a high-performing technical team responsible for the strategy, execution, and implementation of all global lifecycle projects for designated cell therapy products. This role is pivotal in driving innovation, operational excellence, and regulatory compliance across multiple global manufacturing sites, with a direct impact on patient outcomes.

Reporting to senior leadership at Bristol Myers Squibb, the Director partners with matrixed technical teams and multifunctional stakeholders to shape the strategic technology roadmap for cell therapy manufacturing. The role sets standards and directives for manufacturing operations and provides specialized expertise to support site capabilities, investigations, and process improvements.

Key Responsibilities

• Develop and execute the global strategy for cell therapy manufacturing process changes, ensuring alignment with commercial and CMC objectives.
• Own the technical project portfolio for designated cell therapy products, managing schedules, budgets, and resources.
• Lead cross-functional matrix teams to deliver process transformation, improvement, and cost reduction initiatives.
• Drives alignment across CTTO, analytical, quality, regulatory, operations, development, supply chain, program strategy, third-party manufacturing, and manufacturing sites.
• Implements lifecycle management projects and harmonizes manufacturing processes across multiple sites.
• Lead Manufacturing Success Rate (MSR), Robustness, and Cost Reduction initiatives to ensure reliable drug product supply and continuous commercial process transformation.
• Oversee process validation, technology transfer, process qualification, and comparability strategies.
• Lead continuous improvement projects and change control management to enhance product quality, compliance, and supply reliability.
• Lead and oversee the technical package, including project and process risk assessments, governance presentations, and standalone actions to ensure effective project execution.
• Lead and oversee global change controls, CAPAs, proactive initiatives, and standalone actions to maintain compliance and drive improvement.
• Author and review technical content for regulatory submissions (e.g., PPQ, comparability assessments), annual product quality reviews, and technical reports.
• Manage and mentor a technical team, assigning projects and tasks based on strategic priorities.
• Foster a culture of accountability, inclusion, integrity, and innovation.
• Promote diversity, equity, and inclusion in team composition and project execution.

Qualifications & Experience

• Bachelor’s degree or higher in Engineering, Life Sciences, Biology, Chemistry, Biochemical/Chemical Engineering, or related technical discipline.
• Advanced degree (M.S./Ph.D.) preferred; equivalent experience considered.
• 14+ years of relevant experience in cell therapy, biologics, or pharmaceutical manufacturing.
• Proven leadership of technical teams and project in a matrixed environment.
• Expertise in cGMP operations, technology transfer, process validation, regulatory compliance, and change management.
• Deep knowledge of Cell Therapy Drug Product Manufacturing and sterile drug product operations.
• Strong understanding of CMC regulatory requirements, DS & DP manufacturing, and analytical testing.
• Excellent strategic thinking, problem-solving, decision-making, and communication skills.
• Familiarity with project managem