Manager, CMO Operations, VMT Lead (Autologous CAR-T)

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.

Role Overview

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

VMT Leadership & Performance Management

• 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.

Risk Management & Supply Reliability

• 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. 

Continuous Improvement & Capability Building

• 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.

Cross-Functional & External Partnership

• 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.

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.

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