Program Lead, Cell and Gene Therapy

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop advanced cell therapies across an array of technology platforms, including autologous and allogeneic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell–based immunotherapy. From our three R&D sites worldwide, we pursue the discovery of safe, efficacious, and cutting‑edge therapeutics for patients worldwide.

Legend Biotech is seeking a Program Lead, Cell and Gene Therapy as part of the Global Manufacturing and Supply team based in Raritan, NJ
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The program lead will develop and execute the internal commercial manufacturing strategy for iLVV (in vivo Lentiviral Vector). The role leads strategic planning, drives execution, proposes options to senior leadership, and ensures technical excellence, regulatory readiness, operational execution, and seamless cross‑functional alignment. The position requires close collaboration with cross‑functional teams including R&D, process development, MSAT, global facility & engineering, quality, procurement, regulatory affairs, and finance.

• Define and drive the internal commercial manufacturing strategy for iLVV.
• Evaluate internal and external options for iLVV commercial manufacturing and seek stakeholder feedback.
• Present options and recommendations to senior leadership for decision‑making.
• Provide clear, concise, and timely updates to senior management regarding program progress, risks, and strategic considerations.
• Motivate and inspire cross‑functional teams, building momentum, alignment, and ownership.
• Make decisive, data‑driven, and sometimes tough decisions to advance program objectives under aggressive timelines.

• Develop detailed business and implementation plans and timelines for late‑stage clinical and commercial manufacturing to deliver launch milestones.
• Oversee facility fitness and readiness and ensure alignment with stakeholders on commercial tech transfer and production timelines.

• Partner with R&D for process development and technology transfer.
• Work closely with engineering and Somerset facility teams for infrastructure planning.
• Drive decision‑making that balances scientific rigor, speed, risk, and business impact.
• Coordinate with regulatory and quality teams to ensure compliance with global standards.
• Collaborate with finance to manage budgets and cost projections.

• Work with MSAT to drive commercial process transfer activities from development to manufacturing.
• Coordinate generation of process descriptions, control strategies, equipment requirements, and Bill of Materials.
• Drive establishment of raw material requirements, QC method readiness and facility fit.
• Ensure robust scale‑up and validation of vector manufacturing processes.

• Ensure manufacturing facilities are prepared for the new product including capacity, equipment, utilities, and staffing.
• Partner with Supply Chain to secure long‑lead materials, single‑use components, and critical suppliers.
• Oversee line‑of‑business readiness: QA, QC, MSAT, warehouse, digital systems, labeling, analytics.
• Align on operational procedures (SOP updates, batch records, deviations / corrective actions).

• Ensure compliance with applicable global GMP, ICH, and regulatory expectations.
• Support CMC submissions, PPQ documentation, change controls, and validation packages.
• Collaborate with quality to ensure inspection readiness and audit support.

• Identify opportunities to optimize manufacturing robustness, cost, and yield post‑launch.
• Implement lessons learned, knowledge management systems, and NPI best practices.
• Support product lifecycle changes such as process improvements, site expansions, and supply chain enhancements.

BS is required;
Ph.D. preferred in Biotechnology, Biochemical Engineering, or a related field.

• Minimum 10+ years in biopharmaceutical manufacturing;…