Jobs at Allogene Therapeutics

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.

Lead Quality Data Science/Quality Engineering to embed applied statistics, data science, and ML into GMP operations. Build roadmap, drive process and analytical understanding, support regulatory submissions and inspections, enable predict-and-prevent capabilities, root cause investigations, and cross-functional knowledge management to improve product quality for allogeneic CAR T cell therapies.

Provide QA leadership and oversight for CMOs and material suppliers; support GMP manufacturing, disposition, audits, investigations, change control, quality agreements, regulatory submissions, analytical transfers, and continuous improvement activities.

Lead and grow Process Sciences teams to develop robust CAR-T drug substance and drug product processes. Drive DoE/QbD-based process characterization, risk assessments, GMP documentation, technology transfer, and regulatory filing support (IND–BLA). Mentor staff, collaborate cross-functionally and with external partners, and represent the organization in publications and conferences to advance platform process knowledge and commercialization readiness.

Lead product characterization strategy and author regulatory product characterization from IND to BLA for allogeneic CAR T cell products. Drive innovation in analytical methods, collaborate with Process Science, Quality, and Regulatory to define CQAs and control strategies, and characterize gene editing/insertion impacts. Mentor staff, maintain high-quality documentation, and support regulatory interactions while staying current with field and regulatory guidance.

Support development, implementation, and characterization of clinical‑scale CAR‑T manufacturing processes. Design and analyze DoE studies, support non‑GMP and tech transfer activities, contribute to process characterization, continuous improvement, documentation in ELNs and technical reports, and present data to project teams and management.

Provide public-company corporate legal support including SEC reporting, corporate governance, Board and proxy processes, Section 16 and disclosure compliance. Advise on and negotiate corporate and commercial agreements, support M&A, licensing and business development, manage outside counsel, and deliver practical legal advice to cross-functional teams in a biotech environment.

Lead global market access strategy for launch and commercialization of allogeneic CAR T therapies. Own pricing, payer engagement, reimbursement, distribution, patient support, and innovative payment models. Build COE networks and a field reimbursement organization, negotiate coverage and single case agreements, influence payer and policy stakeholders, partner cross-functionally on evidence and value strategy, and ensure compliance to enable broad patient access.

Lead data infrastructure and analysis for GMP cell therapy manufacturing: manage data lakes, ingest/clean/visualize data, develop analytics and ML to support process understanding, PPQ/BLA packages, regulatory readiness, and cross-functional manufacturing and quality initiatives.

Support development and characterization of analytical methods (multicolor flow cytometry, cell-based potency/cytotoxicity, molecular assays) for CAR T product release, stability, and GMP manufacturing; perform data analysis, documentation, tech transfer, and cross-functional collaboration for regulatory submissions.

Support development, characterization, and scale-up of clinical‑scale CAR‑T manufacturing processes. Execute and analyze DoE, support non‑GMP clinical‑scale operations, contribute to process characterization, tech transfer, documentation, regulatory filings, and cross‑functional project teams to improve CAR‑T manufacturing robustness.