Teams at Lyell Immunopharma

Provides CMC regulatory expertise across the product lifecycle for cell therapies. Leads regulatory risk assessment, submission planning, timelines, and CMC content for INDs, amendments, IMPDs, CTAs, BLAs, and MAAs. Coordinates regulatory projects, supports FDA and global health-authority interactions, and develops lifecycle-management practices, templates, and tools. Collaborates cross-functionally with CMC and regulatory teams in a fast-paced biotechnology environment.

Leads global regulatory strategy for CAR-T cell therapy programs from early clinical development through licensure and lifecycle management. Responsibilities include developing regulatory strategies, managing FDA and EMA interactions, leading IND, CTA, BLA, and MAA submissions, mitigating regulatory risks, reviewing clinical and non-clinical documents, collaborating with CMC and clinical teams, monitoring regulatory intelligence, and mentoring regulatory staff.

Performs GMP Quality Assurance activities supporting biopharmaceutical manufacturing, including batch record review, raw material and lot disposition, deviation investigations, CAPA, change control, audits, cleanroom support, and validation review. The role supports cellular therapy and lentiviral vector manufacturing and requires onsite Sunday–Wednesday coverage at the Lyell Manufacturing Facility in Bothell, Washington.