Jobs at Allogene Therapeutics

Leads global quality systems and compliance strategy for clinical development and commercialization readiness. Oversees quality management systems, cGMP compliance, inspection readiness, supplier audits, regulatory inspections, risk management, deviations, CAPA, quality metrics, and continuous improvement. Partners with Manufacturing, Regulatory, and Clinical Quality Assurance while building and coaching a high-performing quality team.

Manage and optimize Allogene's SAP solution landscape: implement updates/upgrades, maintain HANA/HEC environments, enforce SOX/GxP compliance, manage security roles, client/transport structure, integrations, documentation, monitoring, and coordinate internal and external support to meet SLAs.

Lead enterprise AI product roadmap and governance at a biotech firm: evaluate vendor platforms, run proofs-of-concept, define requirements, ensure security/compliance in regulated contexts, drive adoption and training, maintain an AI use-case registry, and present updates to leadership.

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, 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.

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.

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.

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.

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 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.

Manage pharmacovigilance operations including vendor oversight, SAE reporting, safety database and coding support, regulatory and periodic safety report preparation, eTMF filing, CAPA liaison, trackers reconciliation, and support for inspections and cross-functional safety initiatives.

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 comprehensive legal support focused on contracting: prepare and review agreements, manage contract lifecycle via contract management systems, support negotiations and execution, develop standard form agreements and legal processes, assist with due diligence and corporate transactions, and implement legal operations tools and policies.