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CMC Regulatory Affairs at Lyell Immunopharma - ApplyBlast

CMC Regulatory Affairs

Lyell Immunopharma

2 months ago

3.1 on Glassdoor

Seattle, Washington, United States

Onsite

Full Time

Senior

0 applicants

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About this role

The role provides CMC regulatory expertise throughout the product lifecycle for a clinical-stage cell therapy company, interacting with the FDA and leading CMC regulatory risk assessments, documentation, and submission planning. The incumbent collaborates with cross‑functional teams to develop regulatory content for INDs, CTAs, BLAs/MAAs, and other regulatory submissions, while maintaining knowledge of global regulations and best practices.

Responsibilities

Provide phase-appropriate CMC regulatory guidance for cell therapy development
Lead CMC regulatory risk assessment and manage submission timelines
Coordinate development of CMC content for INDs, BLAs and marketing applications

Skills

Qualifications

MScPhD

About Lyell Immunopharma

lyell.com

Headquarters

South San Francisco, California, United States

Company Size

201-500 employees

Founded

2018

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Lyell is a fully integrated biopharmaceutical company developing next‑generation T‑cell reprogramming technologies to create durable CAR T‑cell therapies for hematologic malignancies and solid tumors. Their platform-driven approach spans discovery through clinical development, with active programs and trials such as the PiNACLE study for aggressive B‑cell non‑Hodgkin lymphoma and the recently acquired GCC‑targeted candidate LYL273. Lyell is patient‑focused, aiming to improve outcomes for cancers with significant unmet medical need.