Executive Director, Drug Product Process Development- Cell Therapy

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 rich in diversity. 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.

Summary:

The Executive Director, Drug Product Process Development is accountable for global network of cell therapy DP process development. This role is responsible for driving innovation and implementing end to end practices for leading cell therapy drug product processes and integrating with the global CT operations network strategy. Accountable for holistic cell therapy DP process development strategy to ensure enterprise level considerations are applied across the portfolio of CT assets including all autologous, allogeneic and iPSC/NK based approaches, influencing overall CT development strategy. 

Role & Responsibilities:

• Lead all cell therapy DP process development activities and teams across multiple sites
• Partner and collaborate with Accept, Gene Delivery Process & Analytics Process Development, CT DP Analytics, and GMSAT, and leverage expertise in the broader BMS development functions as required
• Develop and implement cost effective and cost competitive processes for all cell therapy approaches
• Develop phase appropriate FIH processes to enable speed on portfolio delivery
• Define and harmonize global strategies for developing, characterizing and enabling validation of CT drug product processes for both early and late-stage assets as applicable
• Develop and lead global strategy and implementation of DP process strategy aligned with the internal operations network, the R&ED strategy and commercial considerations for CT
• Provide technical oversight of CT process related investigations at internal and external manufacturing sites as required.
• Lead enterprise assessment of novel technologies including automation, expression platforms, and associated IP helping to protect and create value for the BMS portfolio of clinical cell therapy assets
• Responsible for developing and implementation of PAT as it relates to CT DP processes in the network, in partnership with BD
• Partner with GMSAT on automation and LCM for Abecma and Breyanzi including leadership of Breyanzi single train process development
• Build high performing teams that excel at working in matrices across BMS. Attract, hire, manage and develop world class scientific, technical and engineering talents and create an environment where they can thrive.
• Create strong partnerships to continually evaluate and evolve the department’s strategic plan to ensure alignment with business objectives while balancing cost, time and speed.
• Drive engagement with the broader external cell therapy community and influence direction of the field
• Serve as a member of the Cell Therapy Development leadership team, participating in portfolio review and project governance meetings and providing guidance for best practices and direction for continuous improvement.
• Contribute to, review and approve regulatory CMC submissions to ensure their quality and technical content

Requirements:

• PhD preferred in biochemistry, biochemical engineering, or other related field
• Minimum 15 years of experience, leading teams of people (leading leaders) across multiple geographic locations (~25 % travel required)
• Demonstrated experience in developing and establishing process strategies required for early, late, and commercial stage biological/ cell therapy processes
• Experience with integration of process control strategies with understanding of attribute sciences
• Broad understanding of metabolomics and CT characteristics as it relates to production technology
• Experience with multiple analytical techniques used to characterize and quantify CT approaches
• Experience with process characterization of large mo