Sr Principal Engineer – Cell Therapy Technical Operations
| Company | Bristol Myers Squibb |
|---|---|
| Location | Seattle, WA, USA, Summit, NJ, USA, Devens, MA, USA |
| Salary | $143000 – $179000 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- 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
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
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 external manufacturing relationships or working with CMOs