Teams at Allogene Therapeutics

Lead product quality for allogeneic CAR-T programs, overseeing testing, stability, method validation, comparability, OOS/CAPA management, regulatory submissions, inspections, and QC oversight for clinical and commercial manufacturing (internal and CMO). Provide technical and strategic quality input across CMC, support tech transfers, and represent Quality with stakeholders and regulators.

Lead Pilot Plant within Process & Product Development to translate process development into scalable cell therapy manufacturing. Oversee pilot-scale runs, scale-up risk mitigation, design characterization studies (QbD/DOE), implement closed aseptic automation, support technology transfer to GMP, author regulatory documentation, mentor scientists, and collaborate with Drug Product, MSAT, and Manufacturing.

Part-time contract role managing supplier qualification: own supplier questionnaires, develop and negotiate quality agreements, perform periodic reviews, assist supplier monitoring and qualification, and support cross-functional process improvements and special projects.