Associate Director, CMC Regulatory
Lyell Immunopharma · Seattle, WA
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Role summary
Lyell Immunopharma seeks an Associate Director to lead chemistry, manufacturing, and controls regulatory strategy across the product lifecycle for next-generation CAR T-cell therapies. The role involves collaborating with internal teams and FDA on IND submissions, BLA applications, and regulatory documentation while identifying CMC risks and coordinating submission timelines.
What they're looking for
- Master's or PhD in scientific discipline or related field
- Minimum 8 years CMC regulatory affairs experience
- Leadership experience with CMC documentation and lifecycle management from IND through marketing applications
- Cell therapy development experience preferred
- Global regulatory experience preferred
What you'll be doing
- Provide phase-appropriate CMC regulatory guidance for cell therapy development programs
- Lead CMC regulatory risk assessments and escalate critical issues to senior management
- Develop CMC content for INDs, IND amendments, IMPDs, CTAs, BLAs, and MAAs
- Coordinate and manage CMC regulatory project timelines and submissions to health authorities
- Establish company-wide best practices and tools for cell and gene therapy CMC regulatory processes
Privacy & handoff
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