Teams 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.