Principal Engineer, Cell Therapy Tech Ops
Bristol-Myers Squibb
Principal Engineer, Cell Therapy Tech Ops
Job Description
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. Provide technical oversight during manufacturing campaigns, including on-the-floor and remote support during PPQ and routine production. Troubleshoot deviations and support root cause investigations. 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. 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. 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. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. 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. 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.
Key Responsibilities
- 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
- Provide technical oversight during manufacturing campaigns, including on-the-floor and remote support during PPQ and routine production
- Troubleshoot deviations and support root cause investigations
- 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
- 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
- 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
- 0+ 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)
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
Skills Required
- 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
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Locations
- Seattle 400 Dexter, WA
Salary
Estimated Salary Rangemedium confidence
150,000 - 220,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to influence senior stakeholders and align cross-functional teams on complex technical and strategic issuesintermediate
- Proficiency in data analytics and modeling tools (e.g., JMP, R, Minitab)intermediate
- Exceptional communication skills with the ability to translate complex technical content into strategic recommendations for leadershipintermediate
Required Qualifications
- B.S., M.S., or Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related discipline (experience)
- 0+ 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 (experience)
- Demonstrated success leading late-stage development, PPQ strategy, and commercial validation (experience)
- Proven track record managing and influencing external partnerships (CDMOs/CMOs) to achieve strategic outcomes (experience)
- Strong knowledge of ICH guidelines, control strategies, and validation lifecycle frameworks (experience)
- Experience authoring and defending regulatory submissions (INDs, BLAs, variations) (experience)
Preferred Qualifications
- Expertise in cell therapy, immunotherapy, or viral vector manufacturing (experience)
- Experience shaping and executing global strategy across multiple manufacturing sites (experience)
- Prior involvement in global governance forums or steering committees (experience)
- Familiarity with advanced statistical and QbD approaches for process lifecycle management (experience)
Responsibilities
- 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
- Provide technical oversight during manufacturing campaigns, including on-the-floor and remote support during PPQ and routine production
- Troubleshoot deviations and support root cause investigations
- 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
- 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
- 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
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
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Answer 10 quick questions to check your fit for Principal Engineer, Cell Therapy Tech Ops @ Bristol-Myers Squibb.
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Principal Engineer, Cell Therapy Tech Ops
Bristol-Myers Squibb
Principal Engineer, Cell Therapy Tech Ops
Job Description
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. Provide technical oversight during manufacturing campaigns, including on-the-floor and remote support during PPQ and routine production. Troubleshoot deviations and support root cause investigations. 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. 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. 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. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. 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. 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.
Key Responsibilities
- 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
- Provide technical oversight during manufacturing campaigns, including on-the-floor and remote support during PPQ and routine production
- Troubleshoot deviations and support root cause investigations
- 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
- 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
- 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
- 0+ 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)
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
Skills Required
- 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
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Locations
- Seattle 400 Dexter, WA
Salary
Estimated Salary Rangemedium confidence
150,000 - 220,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to influence senior stakeholders and align cross-functional teams on complex technical and strategic issuesintermediate
- Proficiency in data analytics and modeling tools (e.g., JMP, R, Minitab)intermediate
- Exceptional communication skills with the ability to translate complex technical content into strategic recommendations for leadershipintermediate
Required Qualifications
- B.S., M.S., or Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related discipline (experience)
- 0+ 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 (experience)
- Demonstrated success leading late-stage development, PPQ strategy, and commercial validation (experience)
- Proven track record managing and influencing external partnerships (CDMOs/CMOs) to achieve strategic outcomes (experience)
- Strong knowledge of ICH guidelines, control strategies, and validation lifecycle frameworks (experience)
- Experience authoring and defending regulatory submissions (INDs, BLAs, variations) (experience)
Preferred Qualifications
- Expertise in cell therapy, immunotherapy, or viral vector manufacturing (experience)
- Experience shaping and executing global strategy across multiple manufacturing sites (experience)
- Prior involvement in global governance forums or steering committees (experience)
- Familiarity with advanced statistical and QbD approaches for process lifecycle management (experience)
Responsibilities
- 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
- Provide technical oversight during manufacturing campaigns, including on-the-floor and remote support during PPQ and routine production
- Troubleshoot deviations and support root cause investigations
- 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
- 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
- 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
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for Principal Engineer, Cell Therapy Tech Ops @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs