Associate Director, Process Robustness, Cell Therapy Technical Operations (CTTO)

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.

Come and join Bristol Meyers Squibb for this key role helping to build a leading CAR T Platform that serves our patients with novel CAR T Therapies. At BMS, we are developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer. 

The Associate Director, Process Robustness, leads implementation of robustness related initiatives and lifecycle management projects. The successful candidate will lead investigations and implementation of changes that increase process robustness and increase the efficiency of commercial manufacturing. The technical project lead role is responsible for project planning, development, technical assessment, transfer package creation, change control, and implementation across multiple commercial manufacturing sites.

Job Description:

Major job duties include:

• Lead and Interface with manufacturing site operations teams and process/analytical SMEs to implement processes, procedures, and analytics by applying in-depth CAR-T manufacturing process knowledge
• Serve as the interface between the sites, robustness teams, product stewardship, technical product lead, and laboratories to drive control strategy robustness activities for both process and analytical.
• Lead a team of process engineers that support process robustness, trend deviations, and CAPAs.
• Promote innovative and efficient approaches to implementing robustness initiatives for commercial cell therapy products based on risk-based elements and considerations unique to cell therapy production.
• Coordinate project planning, timeline, communications, and risk management activities.
• Support manufacturing, QC and QA throughout transfer by providing training, answering questions, clarifying intent of procedures, solving problems, and contributing to operational strategies.
• Provide technical input and investigation support for deviations/OOS.
• Assist in the management of changes, and in the implementation of process improvements.
• Provide technical input in support of regulatory submissions.
• Interact with other CMC teams including Operations, QA, Development, and Regulatory
• Evaluate and assist in statistical design and execution of comparability exercises for cell therapy products
• Review regulatory filings summarizing the technology transfer and comparability strategy and results.
• Contribute to alignment and harmonization of strategies across multiple sites and stakeholders.

Basic Qualifications:

• Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related experience in biologics upstream manufacturing:  Minimum of a Bachelor’s with 12+ years or a Master’s degree with 10+  years or Ph.D. degree with 8+ of experience
• 3+ years experience managing direct reports and/or matrix teams.
• Extensive knowledge of regulations, current industry practices, and experience with interpretation and application of guidelines and regulations
• A strong mindset for high-quality, meticulous, and consistent execution of manufacturing processes and/or analytics
• Extensive knowledge in Cell Biology and its impact to Cell Therapy Manufacturing
• Extensive cell therapy manufacturing experience and have written Commercial Technical Product Descriptions and Control Strategy documents.
• Strong knowledge and technical leadership and proven track record of managing comparability/similarity projects.
• Established track record of success with