Principal Engineer, Cell Therapy Tech Ops

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:

We are seeking a highly motivated and detail-oriented MSAT Engineer to support AAV (Adeno-Associated Virus) and gene editing manufacturing processes involving CRISPR/Cas systems and RNP (ribonucleoprotein) complexes activities at external Contract Manufacturing Organizations (CMOs). This role is critical for ensuring robust tech transfer, process monitoring, troubleshooting, and continuous improvement of AAV production processes. The ideal candidate will have hands-on experience with upstream and downstream AAV manufacturing, CRISPR/Cas9 or Cas systems, RNP formulation, electroporation, and cell therapy manufacturing, with a strong understanding of GMP operations and analytical technologies.

Key Responsibilities

• Tech Transfer & Process Support
  • Lead and support tech transfers of AAV and gene editing manufacturing processes to CMOs.
  • Support PPQ strategy, planning, and execution for products.
  • Support process development and scale-up of RNP delivery methods.
  • Author and review process documentation including protocols, batch records, and tech transfer packages.
  • Collaborate with internal process development and quality teams to ensure alignment with specifications, process control strategies and CMO capabilities.
  • Monitor critical process parameters and ensure consistency across batches.
  • Analyze process data to identify trends and drive improvements in yield, efficiency, and product quality.
• Manufacturing Oversight
  • Provide technical oversight during manufacturing campaigns, including on-the-floor and remote support during PPQ and routine production.
  • Monitor critical process parameters and performance metrics.
  • Troubleshoot deviations and support root cause investigations.
• Process Improvement
  • Analyze manufacturing data to identify trends and opportunities for optimization.
  • Support implementation of process changes and scale-up activities.
  • Evaluate new technologies and equipment for improved process robustness.
• Documentation, Compliance & Regulatory Support
  • Ensure compliance with GMP and regulatory requirements.
  • Support preparation of regulatory filings (e.g., IND, BLA) with process descriptions and data.
  • Participate in audits and inspections as a technical SME.
  • Contribute to regulatory filings (e.g., IND, BLA) with process descriptions and validation data.
• Cross-Functional Collaboration
  • Act as a liaison between internal stakeholders and CMO teams.
  • Work closely with QA, QC, Regulatory, and Supply Chain to ensure seamless execution of manufacturing campaigns.

Required Qualifications

• B.S., M.S., or Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related discipline with:
  • 10+ years (B.S.), 8+ years (M.S.), or 5+ years (Ph.D.) of experience in biologics or cell therapy process development, tech transfer, or GMP manufacturing support.
• Demonstrated success leading late-stage development, PPQ strategy, and commercial validation.
• Proven track record managing and influencing external partnerships (CDMOs/CMOs) to achieve strategic outcomes.
• Strong knowledge of ICH guidelines, control strategies, and validation lifecycle frameworks.
• Experience authoring and defending regulatory submissions (INDs, BLAs, variations).
• Ability to influence senior stakeholders and align cross-functional teams on complex technical and strategic issues.
• Proficiency in data…