Principal, Quality Assurance
Lyell Immunopharma
August 24, 2026
On-site
Bothell, WA
Operations
Principal, Quality Assurance (Cell Therapy)
Responsibilities:
- Provide Quality oversight and leadership across product lifecycle activities in a cGMP cell therapy environment.
- Lead/oversee process validation and product lifecycle support (PPQ) for Lenti Viral Vector (LVV), plasmids, and drug product(s) including protocol/report review and execution oversight on the manufacturing floor.
- Ensure PPQ strategies evaluate CPPs, CQAs, and in-process controls; assess PPQ data for completeness/accuracy and justified conclusions.
- Ensure deviations during PPQ/validation are investigated, documented, and resolved with minimal schedule impact; maintain traceability between executed studies and IND/BLA submissions.
- Serve as Quality SME on IND/BLA coordination; author/review CMC sections for accuracy, completeness, and GMP compliance.
- Ensure validation/manufacturing/quality documentation is inspection-ready; drive continuous improvement; lead inspection readiness activities.
- Provide Quality oversight for deviations, CAPAs, and change controls.
Required Qualifications/Skills:
- Experience in cGMP clinical manufacturing.
- Experience with electronic quality management systems (deviations, CAPAs, change management).
- Proven ability to oversee QA operations/workflows with timely, compliant execution.
- Ability to work independently and cross-functionally with internal/external partners.
Preferred Qualifications/Skills:
- Experience with plasmid and LVV manufacturing.
- 10–15 years GMP biopharmaceutical operations; 4 years in cell therapy and/or lentiviral manufacturing.
- 5+ years Quality Assurance.
- Direct experience supporting BLA/regulatory filings and/or health authority inspections.
- Commercial manufacturing and post-approval lifecycle management.
Education:
- BS with 15+ years in biochemistry, chemical engineering, bioengineering, or related field.
Compensation/Benefits (if applicable):
- Salary: $150,000–$185,000 annually; annual bonus opportunity; eligible for Equity Incentive Plan.
Application:
- If you’re interested, please apply.
Responsibilities:
- Provide Quality oversight and leadership across product lifecycle activities in a cGMP cell therapy environment.
- Lead/oversee process validation and product lifecycle support (PPQ) for Lenti Viral Vector (LVV), plasmids, and drug product(s) including protocol/report review and execution oversight on the manufacturing floor.
- Ensure PPQ strategies evaluate CPPs, CQAs, and in-process controls; assess PPQ data for completeness/accuracy and justified conclusions.
- Ensure deviations during PPQ/validation are investigated, documented, and resolved with minimal schedule impact; maintain traceability between executed studies and IND/BLA submissions.
- Serve as Quality SME on IND/BLA coordination; author/review CMC sections for accuracy, completeness, and GMP compliance.
- Ensure validation/manufacturing/quality documentation is inspection-ready; drive continuous improvement; lead inspection readiness activities.
- Provide Quality oversight for deviations, CAPAs, and change controls.
Required Qualifications/Skills:
- Experience in cGMP clinical manufacturing.
- Experience with electronic quality management systems (deviations, CAPAs, change management).
- Proven ability to oversee QA operations/workflows with timely, compliant execution.
- Ability to work independently and cross-functionally with internal/external partners.
Preferred Qualifications/Skills:
- Experience with plasmid and LVV manufacturing.
- 10–15 years GMP biopharmaceutical operations; 4 years in cell therapy and/or lentiviral manufacturing.
- 5+ years Quality Assurance.
- Direct experience supporting BLA/regulatory filings and/or health authority inspections.
- Commercial manufacturing and post-approval lifecycle management.
Education:
- BS with 15+ years in biochemistry, chemical engineering, bioengineering, or related field.
Compensation/Benefits (if applicable):
- Salary: $150,000–$185,000 annually; annual bonus opportunity; eligible for Equity Incentive Plan.
Application:
- If you’re interested, please apply.