Sr. Manager Clinical Supply Operations

Legend Biotech is a global biotechnology company dedicated to treating and one day curing life-threatening diseases. Headquartered in Bridgewater New Jersey we are advancing the next generation of cell therapy through a portfolio of innovative technologies including autologous allogeneic and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T) T-cell receptor (TCR-T) natural killer (NK) cell-based therapies and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites we are committed to discovering and developing safe effective and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking aSr. Manager Clinical Supply Operations as part of the Technical Operations team based in Somerset NJ.

Role Overview

Legend Biotech is seeking an experienced and driven Sr. Manager- Clinical 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 will coordinate investigational product planning packaging and labeling distribution inventory quality release returns reconciliation and destruction across clinical sites depots CROs and external vendors. The successful candidate will bring strong operational discipline systems proficiency vendor coordination and cross-functional partnership to help ensure continuous compliant supply of clinical trial material.

Key Responsibilities

• Coordinating supply activities across multiple studies countries sites depots vendors and systems.
• Maintaining accurate inventory visibility while protocols enrollment forecasts shelf life and country requirements evolve.
• Managing temperature excursions expiry risk documentation gaps shipment issues and competing operational priorities.
• Translating cross-functional inputs into timely practical clinical supply actions and clear follow-up.
• Reliable execution of clinical supply plans packaging and labeling activities releases and global distribution.
• Accurate demand forecasts inventory reconciliations expiry tracking returns and destruction records.
• Effective use and oversight of IRT inventory vendor and documentation systems to maintain supply visibility and data integrity.
• Clear operational metrics risk tracking issue escalation and inspection-ready clinical supply documentation.
• Execute day-to-day clinical drug supply activities across assigned trials to maintain availability of investigational product.
• Develop and maintain demand forecasts supply plans resupply parameters inventory targets and risk-mitigation actions in alignment with enrollment and protocol assumptions.
• Coordinate packaging labeling distribution returns reconciliation and destruction activities with internal teams CROs depots clinical sites and external vendors.
• Support studies from start-up through closeout including early-phase programs and evolving study requirements.
• Maintain clinical supply plans pharmacy manuals distribution instructions and other study-specific operational documentation.
• Coordinate clinical label text translation review approval packaging and pack-and-label reconciliation for global studies.
• Coordinate QA and where applicable QP release activities and ensure required documentation is complete before distribution.
• Manage distribution activities and shipment documentation in partnership with logistics providers depots customs support and study teams.
• Coordinate temperature-excursion assessment expiry management product disposition follow-up and documentation closure.
• Support inspection readiness by maintaining complete accurate and traceable clinical supply records including eTMF filing as required.
• Serve as the operational point of contact for assigned packaging labeling depot logistics IRT and other clinical supply vendors.
• Track vendor deliverables timelines performance documentation risks and issue resolution; escalate when needed.
• Partner with Clinical Operations CMC Quality Assurance Regulatory Affairs Technical Development and external partners on shelf life inventory strategy country needs and study execution.
• Identify process gaps and implement fit-for-purpose improvements that support compliance cost timelines data quality and supply continuity.
• Support deviations investigations CAPAs change controls suspected non-compliance assessments and governance activities related to clinical supply operations.
• Independently manage assigned studies and workstreams prioritize competing activities and provide clear status and risk updates.
• Lead operational meetings and ensure decisions actions owners and due dates are documented and followed through.
• Provide guidance to junior team members and contribute to SOPs work instructions training and continuous improvement as the function scales.

Requirements

• Bachelors degree in supply chain life sciences pharmacy business or a related discipline; equivalent relevant experience may be considered.
• Advanced degree or relevant clinical supply certification is preferred but not required.
• 6 years of progressive experience in clinical supply operations clinical drug supply pharmaceutical supply chain or closely related GMP operations within a sponsor CRO or clinical supply service provider environment.
• Demonstrated independent ownership of multiple studies vendors complex workstreams or operational improvements is expected.
• Hands-on experience with clinical supply planning demand forecasting packaging and labeling distribution inventory management reconciliation returns and destruction.
• Experience supporting global clinical trials and working with clinical sites depots CROs packaging providers logistics partners and other external vendors.
• Experience with IRT and clinical supply or inventory systems; familiarity with CTMS eTMF vendor portals ERP reporting tools or related platforms is preferred.
• Working knowledge of GMP requirements QA/QP release temperature excursions expiry management inspection readiness and clinical trial documentation.
• Experience with oncology biologics cell and gene therapy or other complex temperature-controlled products is preferred not required.
• Strong operational ownership attention to detail follow-through and ability to work independently in a fast-moving environment.
• Ability to interpret study needs inventory data forecasts and system outputs and translate them into timely supply actions.
• Effective vendor-management skills including timeline tracking issue resolution escalation and performance follow-up.
• Comfort working across multiple systems and maintaining accurate inspection-ready documentation.
• Strong problem-solving risk-management prioritization and process-improvement skills.
• Clear written and verbal communication and the ability to collaborate effectively across Clinical Operations CMC Quality Regulatory Technical Development and external partners.
• Ability to manage multiple studies and priorities while maintaining compliance responsiveness and supply continuity.

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Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations we participate in the E-Verify program. If you are selected for employment you will be required to complete the Form I-9 process and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair transparent and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race color creed religion national origin ancestry citizenship status age sex or gender (including pregnancy childbirth related medical conditions and lactation) gender identity or gender expression (including transgender status) sexual orientation marital status military service and veteran status disability genetic information or any other protected characteristic under applicable federal state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.