Jobs at Lyell Immunopharma

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.

Lead commercial strategy and launch planning for Lyell's first product, partnering across functions to define indication strategy, brand positioning, market access, budget and KPIs; build commercial infrastructure, vendor relationships, and a high-functioning team to ensure launch readiness and long-term commercial success.

Provide QA leadership and oversight across cell therapy product lifecycle activities including PPQ/validation for LVV, plasmids and drug product; partner with CDMOs and cross-functional teams for process implementation, tech transfer, regulatory submission (IND/BLA) support, inspection readiness, and management of deviations, CAPAs, and change controls to ensure GMP compliance.

Lead clinical-science support for CAR T and cell therapy trials, partnering with medical monitors and cross-functional teams to design protocols, oversee study execution and safety monitoring, analyze and interpret clinical/translational data, support regulatory submissions, manage publications, and collaborate with external stakeholders and vendors to ensure scientific rigor and trial success.