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 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 commercialise 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.

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). This role will lead strategic planning, drive execution, propose options to senior leadership, and manage the commercial manufacturing introduction activities across late‑stage and commercial programmes, ensuring 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/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…