Jobs at Lyell Immunopharma

Perform day-to-day GMP quality assurance tasks supporting manufacturing: review and approve electronic batch records, test results, COAs, raw material disposition, lot disposition, deviations, CAPAs, change control, and nonconformances. Provide cleanroom support, troubleshoot process escalations, perform internal audits, support validation/qualification, and promote continuous improvement and GMP compliance. Onsite role working a Sunday–Wednesday 10-hour shift.

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.

Perform GMP-compliant QC laboratory testing including cell-based release/stability assays, flow cytometry, and lentiviral vector titer/potency assays. Support method transfer, qualification/validation, LIMS test method authoring, deviations/Change Controls/CAPAs, equipment maintenance, and general QC support on a fixed Wed–Sat schedule in an onsite cell therapy-focused facility.

Lead QC analytical strategy and validation for cell therapy release and stability assays (flow cytometry, PCR, cell-based potency). Provide SME support for method transfer, validation per ICH guidance, author CMC quality sections for IND/BLA, support inspections/audits, drive QC continuous improvement, and coordinate across Analytical Development, Manufacturing, Regulatory, and QA for commercialization.

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.

Hands-on IT infrastructure lead responsible for designing, implementing, and operating cloud (AWS), on-premises, identity, networking, security, and collaboration platforms in a regulated life-sciences environment. Owns configurations, governance, MSP oversight, backup/DR, security tooling, and enterprise AI platform administration while ensuring compliance with GxP, SOX, and CSV requirements.