Sr. Principal/Associate Director, Process Engineer

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.

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.

We are looking for a Process Engineer to join the drug product team within the Cell Therapy Technical Operations (CTTO) team. CTTO is responsible for support and harmonization of Cell Therapy Manufacturing Processes across the manufacturing network throughout the product life-cycle from pre-clinical through commercial manufacturing. The Sr. Principal Engineer will be responsible for the implementation of cell therapy manufacturing technologies, including cross-departmental collaboration to enable facility fit, development of process documentation (global guidance documents, process control strategies, process risk assessments, etc), inspection readiness, and technical regulatory submissions. The Sr. Principal Engineer will support commercial product lifecycle management, including authoring of technical assessments and monitoring process performance including, but not limited to, continued process verification. The role collaborates across all CMC functional areas to ensure project advancement, rapid and best in class execution, and communication of challenges/opportunities.

Responsibilities include, but are not limited to, the following:

• Lead process and technology transfers, change management, and technical process support for commercial cell therapy products.
• Owner of process control strategies including process risk assessments and continued process verification.
• Comprehensive data analyses using historical process experience and characterization studies to identify trends in process performance and drive changes in the process control strategy and risk assessments
• Lead production related investigations, ensuring compliance with internal standards and regulatory requirements.
• Own Stage III validation (CPV) reports including process monitoring of manufacturing processes to understand process capability and performance drift over time.
• Provide necessary technical analysis to support impact assessments and investigations.
• Develop, execute and implement manufacturing process improvement activities in accordance with the overall life cycle plan for the product
• Share operational and process leanings with the rest of the manufacturing network

Basic Qualifications:

• MSc, or BSc in Chemical Engineering, Biochemical Engineering or equivalent with minimum of 12+ years of relevant experience. Familiarity with cell therapy processes and cGMPs is preferred.
• Ability to effectively lead cross functional teams, meet deadlines, and prioritize responsibilities.
• Advanced data management and statistical analysis skillset
• Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
• Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs.
• Ability to assess risk and develop contingency plans for process risks
• Able to manage time and elevate relevant issues to project lead and line management.
• Detail oriented with excellent verbal and written communication skills.
• Strong interpersonal and leadership skills to work with teams in different functions and organizations

Preferred Qualifications:

• Experience with cell therapy process development and / or manufacturing
• Experience with technology transfer in a manufacturing environment
• Proficiency utilizing MS Office products a