Sr. Specialist or Principal, Quality Assurance
Lyell Immunopharma · Bothell, WA
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Role summary
Lyell Immunopharma seeks a senior quality assurance specialist or principal to provide quality oversight across cell therapy product lifecycle activities in Bothell, Washington. The role involves partnering with manufacturing, process development, and regulatory teams to support process implementation, validation, and commercialization while ensuring GMP compliance.
What they're looking for
- Experience with process validation and PPQ in cell or gene therapy manufacturing
- Knowledge of GMP requirements and regulatory expectations for biologics
- Demonstrated expertise in quality oversight across product lifecycle stages
- Experience partnering cross-functionally with manufacturing and regulatory teams
- Familiarity with lentiviral vector or plasmid manufacturing processes
What you'll be doing
- Oversee process validation activities for lentiviral vectors, plasmids, and drug products
- Serve as quality representative on cross-functional project teams
- Partner with manufacturing, process development, and regulatory on process improvements
- Support clinical and commercial milestone timelines while ensuring GMP compliance
- Provide CDMO quality oversight and regulatory submission support
Privacy & handoff
This role links to Lyell Immunopharma's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.