Sr. Manager Clinical Supply Operations at Legend Biotech

Somerset, New Jersey, United StatesFull-timePatient Supply Strategy & OperationsPosted 20 days ago

About the Role

<div class="content-intro">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.</div>Legend Biotech is seeking a Sr. 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 <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Coordinating supply activities across multiple studies, countries, sites, depots, vendors, and systems.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Maintaining accurate inventory visibility while protocols, enrollment forecasts, shelf life, and country requirements evolve.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Managing temperature excursions, expiry risk, documentation gaps, shipment issues, and competing operational priorities.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Translating cross-functional inputs into timely, practical clinical supply actions and clear follow-up.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Reliable execution of clinical supply plans, packaging and labeling activities, releases, and global distribution.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Accurate demand forecasts, inventory reconciliations, expiry tracking, returns, and destruction records.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Effective use and oversight of IRT, inventory, vendor, and documentation systems to maintain supply visibility and data integrity.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Clear operational metrics, risk tracking, issue escalation, and inspection-ready clinical supply documentation.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Execute day-to-day clinical drug supply activities across assigned trials to maintain availability of investigational product.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Develop and maintain demand forecasts, supply plans, resupply parameters, inventory targets, and risk-mitigation actions in alignment with enrollment and protocol assumptions.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Coordinate packaging, labeling, distribution, returns, reconciliation, and destruction activities with internal teams, CROs, depots, clinical sites, and external vendors.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Support studies from start-up through closeout, including early-phase programs and evolving study requirements.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Maintain clinical supply plans, pharmacy manuals, distribution instructions, and other study-specific operational documentation.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Coordinate clinical label text, translation, review, approval, packaging, and pack-and-label reconciliation for global studies.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Coordinate QA and, where applicable, QP release activities and ensure required documentation is complete before distribution.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Manage distribution activities and shipment documentation in partnership with logistics providers, depots, customs support, and study teams.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Coordinate temperature-excursion assessment, expiry management, product disposition follow-up, and documentation closure.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Support inspection readiness by maintaining complete, accurate, and traceable clinical supply records, including eTMF filing as required.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Serve as the operational point of contact for assigned packaging, labeling, depot, logistics, IRT, and other clinical supply vendors.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Track vendor deliverables, timelines, performance, documentation, risks, and issue resolution; escalate when needed.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Partner with Clinical Operations, CMC, Quality Assurance, Regulatory Affairs, Technical Development, and external partners on shelf life, inventory strategy, country needs, and study execution.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Identify process gaps and implement fit-for-purpose improvements that support compliance, cost, timelines, data quality, and supply continuity.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Support deviations, investigations, CAPAs, change controls, suspected non-compliance assessments, and governance activities related to clinical supply operations.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Independently manage assigned studies and workstreams, prioritize competing activities, and provide clear status and risk updates.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Lead operational meetings and ensure decisions, actions, owners, and due dates are documented and followed through.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provide guidance to junior team members and contribute to SOPs, work instructions, training, and continuous improvement as the function scales.</li> </ul> Requirements <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Bachelor’s degree in supply chain, life sciences, pharmacy, business, or a related discipline; equivalent relevant experience may be considered.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Advanced degree or relevant clinical supply certification is preferred but not required.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Demonstrated independent ownership of multiple studies, vendors, complex workstreams, or operational improvements is expected.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Hands-on experience with clinical supply planning, demand forecasting, packaging and labeling, distribution, inventory management, reconciliation, returns, and destruction.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience supporting global clinical trials and working with clinical sites, depots, CROs, packaging providers, logistics partners, and other external vendors.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience with IRT and clinical supply or inventory systems; familiarity with CTMS, eTMF, vendor portals, ERP, reporting tools, or related platforms is preferred.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Working knowledge of GMP requirements, QA/QP release, temperature excursions, expiry management, inspection readiness, and clinical trial documentation.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience with oncology, biologics, cell and gene therapy, or other complex temperature-controlled products is preferred, not required.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Strong operational ownership, attention to detail, follow-through, and ability to work independently in a fast-moving environment.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to interpret study needs, inventory data, forecasts, and system outputs and translate them into timely supply actions.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Effective vendor-management skills, including timeline tracking, issue resolution, escalation, and performance follow-up.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Comfort working across multiple systems and maintaining accurate, inspection-ready documentation.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Strong problem-solving, risk-management, prioritization, and process-improvement skills.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Clear written and verbal communication and the ability to collaborate effectively across Clinical Operations, CMC, Quality, Regulatory, Technical Development, and external partners.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to manage multiple studies and priorities while maintaining compliance, responsiveness, and supply continuity.</li> </ul> #Li-JR1 #Li-Onsite<div class="content-pay-transparency"><div class="pay-input"><div class="description">The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles. Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.</div><div class="title">Pay Range (Base Pay): </div><div class="pay-range">$146,410—$192,164 USD</div></div></div><div class="content-conclusion">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. <div>For information related to our privacy notice, please review: <a href="https://legendbiotech.com/privacy-notice/" target="_blank">Legend Biotech Privacy Notice</a>.</div></div>

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