Manager​/Senior Manager, Patient Supply Operations

Manager/Senior Manager, Patient Supply Operations

Location:

New Jersey, US

Compensation: $111k – $167k

Full responsibilities, required qualifications, and compensation details are listed below.

Legend Biotech US is hiring a Manager/Senior Manager, Patient Supply Operations. This is a full‑time role in New Jersey that reports to the Director of Patient Supply Strategy & Operations. The incumbent will support hands‑on execution of global patient supply activities for early clinical Cell and Gene Therapy programs (allogenic and in‑vivo). The 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.

This is a hands‑on role requiring strong ownership of execution, vendor oversight, accountability, and independent issue resolution in a fast‑moving early‑phase environment.

• 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.
• Executing FIH and early‑phase global clinical shipments.
• Establishing global depot and logistics network, including ex‑US infrastructure.
• Defining and implementing import/export workflows and IOR/EOR models.
• Executing per‑country‑specific clinical supply playbooks and SOPs.
• Operating 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.
• 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 customs 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 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, returns, reconciliation, and destruction.
• Monitor depot and site inventory levels; proactively manage resupply and risk scenarios.
• Develop dashboards, KPI, and reporting to support supply decision‑making.

• Partner with Quality to ensure QP release processes are operationally executable and documented.
• Support selection and readiness of depots, including licensing, permits, and quality requirements, in collaboration with Quality.
• Support deviation management, CAPAs, and change controls related to patient supply operations.
• Provide senior oversight of CMOs, depots, couriers, and CROs.
• Serve as patient supply partner to Clinical Operations, CMC, Quality, Regulatory, and Technical Development.
• Lead SOP development, governance forums, and continuous improvement initiatives.
• Mentor junior team members as the function…