Sr Principal Engineer, Cell Therapy Technical Operations

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.

Our Cell Therapy platform is built on Chimeric Antigen Receptor (CAR) technology, enabling the re-engagement of the immune system to treat cancer.

Join the Cell Therapy Development and Operations (CTDO) division, where we are building leading cell therapy platforms to serve patients with novel immunotherapies. The Cell Therapy Technical Operations (CTTO) group within CTDO plays a critical role in:

• Technology transfer and process validation
• CMC lifecycle management
• Oversight of external manufacturing partners
• Process engineering and standardization to support global manufacturing scale-up and robustness

We are seeking a Senior Principal Process Engineer to join our CTTO team.

Position Summary

The Senior Principal Process Engineer will lead the transfer and lifecycle management of manufacturing processes from development through commercialization. This includes facility fit assessments, development of GMP documentation (e.g., batch records, forms), training, quality systems engagement (e.g., change controls), and cross-functional collaboration.

The successful candidate will support late-phase clinical and commercial programs, including PPQ strategy development, regulatory filings, and technical oversight. This individual will serve as a key technical leader across the product lifecycle, driving innovation, alignment, and harmonization across internal and external manufacturing networks.

Primary Responsibilities

• Lead cross-functional technology transfers for both cell therapy and vector manufacturing processes
• Oversee development and implementation of process control strategies, including risk assessments, range justifications, and CPV strategies
• Author and contribute to regulatory filings (e.g., IND, BLA, variations) across product lifecycle stages
• Monitor and evaluate process performance to ensure capability and robustness; support technical investigations as needed
• Develop and manage tools/templates for criticality assessments of process parameters and quality attributes
• Provide technical input into facility and equipment design for clinical and commercial use
• Drive alignment and harmonization of manufacturing processes across internal and external sites
• Foster strong partnerships with Contract Manufacturing Organizations (CMOs) and other external stakeholders
• Provide technical mentorship to junior engineers on complex issues

Required Qualifications

• B.S., M.S., or Ph.D. in Chemical Engineering, Biochemical Engineering, or a related discipline with:
  • 7+ years of relevant experience in biologics or cell therapy process development, tech transfer, or GMP manufacturing support
• Proven ability to operate in cross-functional teams and manage multiple priorities in a fast-paced environment
• Hands-on experience in GMP manufacturing environments and deep understanding of process development and validation
• Familiarity with ICH guidelines, control strategy development, and quality systems (change control, deviations, CAPAs)
• Strong problem-solving skills with proficiency in data analysis tools (e.g., JMP, R, Minitab)
• Effective written and verbal communication skills, including technical documentation and scientific writing
• Detail-oriented, organized, and self-motivated

Preferred Qualifications

• Experience authoring regulatory submissions (e.g., INDs, BLAs)
• Understanding of cellular immunology or immunotherapy platforms
• Experience with single-use technologies (SUBs, SUMs), cell culture, and downstream processing
• Prior experience managing ext