Senior Process Engineer I, CTTO Drug Product

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.

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.

Position Summary

BMS Cell Therapy Development Organization (CTDO) is 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.

We are looking for a Manager / Senior Engineer to join the Breyanzi Product Stewardship Cell Therapy Technical Operation (CTTO) department. The position can be based out of Summit, NJ, USA or Seattle, WA, USA.

This senior engineer will be responsible for the implementation of cell therapy manufacturing technologies, and process changes related to the life-cycle management of a commercial CAR-T Therapy. This includes establishing the strategy for process changes, coordinating technical alignment, and lead implementation at a global level. This highly cross-functional role collaborates across all CMC functional areas and drug product manufacturing sites to ensure project advancement, rapid and best-in-class execution, and communication of challenges/opportunities. The candidate will help drive the validation, qualification, and comparability strategies.

Key Responsibilities

• Develop and implement process improvement projects to improve robustness, scalability, and Cost of Goods (COGs) for cell therapy products.
• Develop product technical strategies including manufacturing requirements, process improvement plans, and ensure successful and timely execution working across functional groups.
• Maintain oversight of process capability through data trending and statistical analysis of critical variables, ensure processes are robust, in a continued state of validation, and continuously improving.
• Provide technical content for significant documents such as validation activities, author content for regulatory submissions.
• Ensure technical and manufacturing requirements are addressed throughout lifecycle of new solutions.
• Provide necessary technical analysis to support impact assessments and investigations.
• Function as a subject matter expert for autologous T-cell therapies and manufacturing technologies.
• Provide technical input and requirements for design of future clinical and commercial manufacturing facilities.
• Present complex technical topics internally and externally.
• Share operational and process leanings with the rest of the manufacturing network

Qualifications & Experience

• B.S. with 6+ years or M.S. with 5+ years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline
• Ability to effectively work in cross functional teams, meet deadlines as an individual contributor, and prioritize responsibilities.
• Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
• Strong interpersonal and leadership skills to work with teams in different functions and organizations
• Excellent verbal & written communications skills. Interpersonal and facilitation skills necessary to lead people and multi-disciplinary teams. Detail oriented with excellent verbal and written communication skills.
• Strong leader