Manager​/Sr. Manager, Patient Supply Operations

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 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 combines the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking an experienced and driven Manager / Sr. Manager – Patient Supply Operations to join our Technical Development team. This role reports to the Director of Patient Supply Strategy & Operations and is responsible for supporting the hands‑on execution of global patient supply activities for early clinical Cell and Gene Therapy programs (Allogenic and In‑Vivo). The role is accountable for operational readiness of investigational product supply from IND through First‑In‑Human and early Phase studies, in alignment with regulatory requirements.

The successful candidate will translate clinical and CMC needs into executable supply plans, ensure compliant distribution, inventory control, and QP release, and partner cross‑functionally to enable uninterrupted delivery of product to global clinical sites.

• Building global supply chain infrastructure in an early‑phase, rapidly evolving environment.
• Executing first‑time country start‑ups, particularly in ex‑US regions with regulatory requirements.
• Managing import/export processes and IOR/EOR models across multiple countries.
• Ensuring reliable delivery of temperature‑sensitive products (LN2, –80°C).
• Responding to real‑time logistics issues while maintaining compliance and timelines.

• Execution of FIH and early‑phase global clinical shipments.
• Establish global depot and logistics network, including ex‑US infrastructure.
• Define and implement import/export workflows and IOR/EOR models.
• Execute per‑country specific clinical supply playbooks and SOPs.
• Operational cold‑chain distribution lanes with defined performance metrics.

• Own and execute global patient supply for early‑phase programs, aligned with clinical development plans and evolving protocol requirements as per program strategy.
• Operationalize bulk vs. per‑patient distribution strategies, safety stock policies, and contingency plans.
• Assist in developing supply manuals and SOPs for global clinical distribution including country specific clinical supply playbooks covering labeling, distribution, and inventory models.
• Support label design for primary and secondary packaging for the drug products in compliance with regional requirements.

• Manage end‑to‑end global shipments including preparation of shipping documentation and coordination with couriers and custom brokers.
• Lead and execute import/export processes, including establishment and oversight of Importer of Record (IOR) and Exporter of Record (EOR) models.
• Support country start‑up activities, particularly in ex‑US regions (EU, APAC, LATAM).
• Support in selection, qualification, and operational readiness of global depots.
• Oversee cold‑chain logistics (LN2 and –80°C), including lane qualification and performance monitoring.
• Serve as escalation point for real‑time shipment issues (customs delays, temperature excursions, documentation gaps).

• Lead evaluation, execution, and implementation of inventory management systems (e.g., SAP, IRT, third‑party depots, clinical sites) for DP and APH materials.
• Own global inventory controls, including lot status, expiry management,…