Manager, CMO Operations, VMT Lead (Autologous CAR-T)
About The Position
Legend Biotech is seeking a Manager, CMO Operations - VMT Lead (Autologous CAR T) as 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.
Requirements
- 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 CMOs and/or CROs in a regulated manufacturing environment.
- Strong understanding of GMP operations, deviation management, and supply risk management.
- Proven ability to operate effectively in fast-paced, high-complexity, patient-critical manufacturing environments.
- Strong analytical, problem-solving, and critical-thinking capabilities.
- Excellent communication and stakeholder-management skills across technical and leadership audiences.
- Ability to lead through influence in a matrixed, cross-functional organization.
- Results-driven mindset with strong execution discipline and attention to detail.
- Solid business acumen and experience driving change and continuous improvement.
Nice To Haves
- cell therapy and/or autologous CAR-T experience is highly preferred.
Responsibilities
- 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.
Benefits
- Medical, dental, and vision insurance
- 401(k) retirement plan with a company match that vests fully on day one
- Eight (8) weeks of paid parental leave after just three (3) months of employment
- Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
- Flexible spending and health savings accounts
- Life and AD&D insurance
- Short- and long-term disability coverage
- Legal assistance
- Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
- Voluntary commuter benefits
- Family planning and care resources
- Well-being initiatives
- Peer-to-peer recognition programs
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What This Job Offers
Job Type
Full-time
Career Level
Manager
