Manager, Senior Engineer I, Global Process Technical Services- 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.

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

Position Summary:

Global Manufacturing Sciences and Technology is responsible for tech transfer, support and harmonization of Cell Therapy Manufacturing Processes across the manufacturing network throughout the product lifecycle from pre-clinical through commercial manufacturing. The Sr. Process 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 requirements for the manufacturing process, coordinating technical transfers to manufacturing and between sites, developing process qualification, process control and comparability strategies, authoring technical sections of major regulatory documents and contributing to the overall CMC and commercial strategy. The Sr. Process Engineer will 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 incumbent will help drive the validation, qualification and comparability strategies and be viewed as a subject matter expert internally and externally in cell therapy drug product manufacturing technology.

Duties/Responsibilities:

• Lead the commercial lifecycle plan for a cellular product, 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.
• Perform and lead data monitoring of manufacturing processes to understand process capability and to increase robustness and sustainability tied improve process robustness or address Investigational trends
• Develop product technical strategies including manufacturing requirements, process improvement plans, post approval life cycle management plans and ensure successful and timely execution working across functional groups.
• Provide support on strategic initiatives including tech transfers, process validation, technical reports, data analysis, process monitoring, change control, product comparability and second line support of technical/scientific process and analytical issues.
• Collaborate with Technical Development, manufacturing sciences and technology and manufacturing operations groups on lifecycle improvements.
• Provide technical content for significant documents such as PPQ or comparability assessments, author content for regulatory submissions, present technical strategies during major health authority interactions and inspections.
• Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
• 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:

• Bachelor’s or Graduate degree in Chemical Engineering, Biomedical Engineering or Life Sciences with more than 5 years of experience in Biotech industry. Familiarity with cell therapy processes and cGMPs is preferred.
• Ability to effectively work in cross functional teams, meet deadlines as