Description

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.

#Li-RP1

#Li-Hybrid

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.

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

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