Legend Biotech US
Manager, CMO Operations, VMT Lead (Autologous CAR-T)
Raritan, New Jersey, United States
Sponsorship not specifiedDetected 26 days ago
Supply ChainProcess ImprovementPerformance ManagementGMPLeadershipCommunicationCollaborationProblem Solving
About the role
- 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.
- 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.
Responsibilities
- Own end-to-end operational execution at CMOs from apheresis through final drug product release and shipment.
- Track and manage batch status, deviations, and execution risks across the full manufacturing lifecycle.
- 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.
- maintain risk registers and mitigation plans.
- Lead cross-functional problem-solving to address deviations, supply interruptions, and systemic issues.
- Proactively identify operational, capacity, and compliance risks; maintain risk registers and mitigation plans.
- 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.
Requirements
- Bachelor's degree or higher in engineering, biological sciences, pharmaceutical sciences, or a related technical discipline.
- 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.
Nice to have
- cell therapy and/or autologous CAR-T experience is highly preferred.
- Minimum of 5 years relevant industry experience in biologics CMC development or commercial manufacturing
Skills
- Ensure flawless and compliant execution of commercial manufacturing plans in alignment with patient schedules and demand forecasts.
- Track, compile, review and report on KPI performance metrics on a regular basis
- Translate operational data into actionable insights for senior leadership decision-making.
- Ensure robust contingency planning to protect patient supply and commercial commitments.
- Promote operational excellence, standardization, and best-practice sharing across the external manufacturing network.
- Provide clear, timely communication to stakeholders on status, risks, and mitigation strategies.
Compensation
- The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting.
Benefits
- Performance-based bonus and/or equity is available to employees in eligible roles.
- Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one.
Apply directly at Legend Biotech US →Create a free account for alerts like thisView Legend Biotech US immigration profile
This listing is sourced directly from Legend Biotech US's careers page and normalized into a canonical job model.