Manager/Sr. Manager, Patient Supply Operations

Legend Biotech US • Somerset, NJ

1d • $110,706 - $167,099 • Onsite

About The Position

Legend Biotech is seeking an experienced and driven Manager/Sr. Manager- Patient Supply Operations to join our Technical Development team. This role will report to the Director of Patient Supply Strategy & Operations and be responsible for supporting hands on execution of global patient supply activities for early clinical Cell and Gene Therapy programs (Allogenic and In-Vivo). This 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. This is a hands-on role requiring strong ownership of execution, vendor oversight, accountability, independent issue resolution in a fast-moving early phase environment.

Requirements

• BS or MS Degree in Supply Chain, Pharmacy or equivalent discipline is required . Advanced technical training and experience preferred.
• 8+ years of experience in clinical supply chain, patient supply, or GMP operations within a sponsor or CRO environment.
• Demonstrated strategic ownership of early‑phase (FIH, Phase I) patient supply programs.
• Direct experience supporting allogeneic and/or in‑vivo therapies, including complex cold‑chain and non‑patient‑specific supply model is preferred.
• Proven expertise managing global clinical shipments.
• Experience with GMP, cell therapy logistics is highly desirable.
• Experience with temperature-controlled shipments, logistics, and E-Systems is highly desirable.
• Development of collaboration, influencing, and negotiation skills to work effectively with internal cross- functional groups and external suppliers to meet the aggressive clinical study timeline and patient needs.
• Collaborative, team-oriented mindset with strong verbal and written communication skills.
• Ability to communicate clearly and effectively with all levels of the organization.
• Understanding of escalation processes and requirements.
• Good written and verbal skills.
• Ability to work hands on, independently and successfully prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.

Nice To Haves

• Direct experience supporting allogeneic and/or in‑vivo therapies, including complex cold‑chain and non‑patient‑specific supply model is preferred.
• Experience with GMP, cell therapy logistics is highly desirable.
• Experience with temperature-controlled shipments, logistics, and E-Systems is highly desirable.

Responsibilities

• 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, 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 scales.

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement plan with a company match that vests fully on day one
• Eight (8) weeks of paid parental leave after just three (3) months of employment
• Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
• Flexible spending and health savings accounts
• Life and AD&D insurance
• Short- and long-term disability coverage
• Legal assistance
• Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
• Voluntary commuter benefits
• Family planning and care resources
• Well-being initiatives
• Peer-to-peer recognition programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level