Bristol Myers Squibb
Principal Engineer, Cell Therapy Tech Ops
Bristol Myers Squibb, Seattle, Washington, us, 98127
Principal Engineer, Cell Therapy Tech Ops
Apply for the Principal Engineer, Cell Therapy Tech Ops role at Bristol Myers Squibb.
Working with Us Challenging. Meaningful. Life‑changing. 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 grow and thrive through opportunities uncommon in scale and scope, alongside high‑achieving teams. Take your career farther than you thought possible.
We offer a wide variety of competitive benefits, services and programs that help employees pursue their goals at work and in their personal lives. Read more:
careers.bms.com/working-with-us .
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‑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.
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 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.
Preferred Qualifications
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.
Compensation Overview Seattle – WA: $164,020 – $198,759 annual base salary, plus incentive cash and stock opportunities. Total compensation is based on experience and qualifications.
Benefits include medical, pharmacy, dental, vision, wellness programs, 401(k), paid vacation, paid holidays, and additional perks.
Work Location Site‑essential; 100% onsite required at the assigned facility.
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Working with Us Challenging. Meaningful. Life‑changing. 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 grow and thrive through opportunities uncommon in scale and scope, alongside high‑achieving teams. Take your career farther than you thought possible.
We offer a wide variety of competitive benefits, services and programs that help employees pursue their goals at work and in their personal lives. Read more:
careers.bms.com/working-with-us .
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‑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.
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 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.
Preferred Qualifications
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.
Compensation Overview Seattle – WA: $164,020 – $198,759 annual base salary, plus incentive cash and stock opportunities. Total compensation is based on experience and qualifications.
Benefits include medical, pharmacy, dental, vision, wellness programs, 401(k), paid vacation, paid holidays, and additional perks.
Work Location Site‑essential; 100% onsite required at the assigned facility.
#J-18808-Ljbffr