Senior Director CTTO External Manufacturing & Tech Transfer

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.

Title: Senior Director, CTTO External Manufacturing & Tech Transfer

Location: Seattle, WA, Summit, NJ, or Devens, MA

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Sr. Director, External Manufacturing & Operations is BMS’s primary point of contact for external Contract Manufacturing Organization (CMO) network for Drug Product operations. This position provides technical support and leadership to CMO operations in Europe, and Japan with ownership of the technical aspects of the cell therapy manufacturing process for commercial products. This is a key technical role providing technical support for routine manufacturing operations process improvement, lifecycle management and technical transfers of products technologies and processes to the CMO manufacturing sites, developing process qualification, process control and comparability strategies, supporting major regulatory submission and contributing to the overall CMC and commercial strategy. This Team will also leverage other functions within BMS such as process and analytical development, quality, regulatory, manufacturing and supply chain to drive external manufacturing excellence.

Key Responsibilities:

• BMS’s primary point of contact for external Contract Manufacturing Organization (CMO) network for Drug Product operations.
• Provides technical support and leadership to CMO operations in Europe, and Japan with ownership of the technical aspects of the cell therapy manufacturing process for commercial products.
• Support for routine manufacturing operations process improvement and lifecycle management. 
• Accountable for establishing the requirements for the commercial manufacturing process, coordinating technical transfers to the CMO manufacturing sites, developing process qualification, process control and comparability strategies, supporting major regulatory submission and contributing to the overall CMC and commercial strategy.
• Provide ongoing technical oversight to manufacturing, defining and driving a long-term process improvement lifecycle plan and ensuring successful execution of the technical strategy.
• Work cross-functionally across technical operations and with the external CMO’s and technical teams leveraging other functions within BMS such as process and analytical development, quality, regulatory, manufacturing and supply chain counterparts.
• Drive the External manufacturing excellence and technology transfer, validation, qualification and comparability strategies.
• Technical leader for external Manufacturing operations of cell therapy drug product manufacturing technology.
• Own the technology transfer of the commercial assets including ownership of the tech transfer plan and final report.
• Develop product technical strategies including manufacturing requirements, process improvement plans as part of the technology transfer and help define the post approval life cycle management plans and ensure successful and timely execution working across functional groups.
• Provide technical leadership on strategic initiatives including tech transfers, process validation, technical reports, data analysis, process monitoring, change control, and product comparability.
• Collaborate with Technical Development groups on lifecycle imp