Principal Engineer, Cell Therapy Tech Ops

Bristol Myers Squibb•Seattle, WA

About The Position

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 . 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.

Requirements

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 analytics and modeling tools (e.g., JMP, R, Minitab).
Exceptional communication skills with the ability to translate complex technical content into strategic recommendations for leadership.

Nice To Haves

Expertise in cell therapy, immunotherapy, or viral vector manufacturing.
Experience shaping and executing global strategy across multiple manufacturing sites.
Prior involvement in global governance forums or steering committees.
Familiarity with advanced statistical and QbD approaches for process lifecycle management.

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.
Participate in audits and inspections as a technical SME.
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.

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

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