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

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.
• Able 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.

Pay Range

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles. Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Pay Range (Base Pay): $110,706 - $145,303 USD