Manager, CMO Operations, VMT Lead (Autologous CAR-T
Listed on 2026-08-22
-
Business
Operations Management, Regulatory Compliance Specialist
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Manager, CMO Operations - VMT Lead (Autologous CAR T) – part of the Global Manufacturing & Supply team based in Raritan, NJ
.
The Manager, CMO Operations - VMT Lead is responsible for end-to-end operational oversight of Contract Manufacturing Organizations (CMOs) supporting the commercial manufacture of autologous CAR‑T cell therapy products. Acting as the Value Management Team (VMT) Lead, this role owns day-to-day execution, performance management, and risk oversight for external manufacturing operations, ensuring reliable, compliant, and on time delivery of patient‑specific drug product.
This position serves as the primary operational interface between internal cross-functional teams and external manufacturing partners, driving operational excellence, continuous improvement, and supply reliability in a highly complex, patient‑critical manufacturing environment.
Key Responsibilities CMO Operations & Execution- Own end-to-end operational execution at CMOs from apheresis through final drug product release and shipment.
- Ensure flawless and compliant execution of commercial manufacturing plans in alignment with patient schedules and demand forecasts.
- Track and manage batch status, deviations, and execution risks across the full manufacturing lifecycle.
- Track, compile, review and report on KPI performance metrics on a regular basis.
- Serve as the VMT Lead for assigned CMOs, driving structured performance management using agreed KPIs and governance processes.
- Lead routine business reviews, performance deep dives, and escalation forums with CMOs and internal stakeholders.
- Translate operational data into actionable insights for senior leadership decision‑making.
- Proactively identify operational, capacity, and compliance risks; maintain risk registers and mitigation plans.
- Lead cross‑functional problem‑solving to address deviations, supply interruptions, and systemic issues.
- Ensure robust contingency planning to protect patient supply and commercial commitments.
- Drive continuous improvement initiatives at CMOs to enhance reliability, cycle time, yield, and right‑first‑time performance.
- Support execution of capacity expansions, technology transfers, and process improvement projects.
- Promote operational excellence, standardization, and best‑practice sharing across the external manufacturing network.
- Build and maintain strong working relationships with internal functions including Quality, MSAT, Planning, Supply Chain, and Clinical/Commercial Operations.
- Act as a trusted partner to external CMOs, fostering transparency, accountability, and a culture of continuous improvement.
- Provide clear, timely communication to stakeholders on status, risks, and mitigation strategies.
- Bachelor’s degree or higher in engineering, biological sciences, pharmaceutical sciences, or a related technical discipline.
- Minimum of 5 years relevant industry experience in biologics CMC development or commercial manufacturing; cell therapy and/or autologous CAR‑T experience is highly preferred.
- Demonstrated hands‑on experience managing…
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).