Company Profile

Legend Biotech USA

Company Overview

Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 1,000 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture cutting edge cell therapies for patients in need.

Company History

Legend Biotech was founded as an early-stage cell therapy company in 2014. The company was the brainchild of visionary scientists who recognized that antibody-based therapeutics could potentially treat disease and possessed the backgrounds in immunology and gene editing to take the leap.

For two years, Legend Biotech, then known as the “Legend Project,” operated in a room the size of a freight elevator, with the goal of creating a cell therapy for multiple myeloma, a hematological cancer that often relapses and can become refractory. The team produced nanobodies for single-domain antibody drugs and ultimately extended the half-life of the nanobodies with proprietary technologies.

In 2015, Legend’s scientists focused on research for chimeric antigen-receptor T-cells (CAR-T) targeting the BCMA protein, making the biotech one of the first companies in the world to engineer CAR-T cells for the BCMA protein. In 2016, investigator-initiated trials began in China.

In 2017, data from the trials were presented at the American Society for Clinical Oncology (ASCO), which led to a partnership with biopharmaceutical company Janssen Biotech, Inc. to co-develop the anti-BCMA CAR-T, ciltacabtagene autoleucel (cilta-cel). Applications seeking approval of cilta-cel for the treatment of patients with RRMM are currently under regulatory review by several health authorities around the world. CARVYKTI™ (ciltacabtagene autoleucel) was approved by the U.S. Food and Drug Administration in February 2022 and received conditional marketing approval from the European Medicines Agency in May 2022.

Today Legend Biotech is a global, commercial-stage company driven by a passion for patients. We continue to build our pipeline of cell therapy platforms, which includes CAR-T, CAR-NK, CAR-?? T and non-gene-editing CAR technologies.

Our goal is to bring hope and opportunity to patients and their families by continuing to explore unique technologies.

Positions Available
  • 1 day ago

    Sr. Manager, CQA GLP

    Legend Biotech USA - Somerset, NJ, United States

    Legend Biotech is seeking a Manager/Sr. Manager, GLP - CQAas part of the Regulatory Affairsteam based in Somerset, NJ. Role OverviewThe incumbent/appointee will be responsible for ensuring that the relevant nonclinical studies are performed in compliance with GLP regulations and Health Authorities' guidance/principles, and/or EDD's established quality standards. He/she will maintain a compliant quality system to meet these requirements, and will be responsible for the overall (GLP) quality ...

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  • 1 day ago

    Associate Director, GxP Compliance and Auditing

    Legend Biotech USA - Bridgewater, NJ, United States

    Legend Biotech is seeking an Associate Director, GxP Compliance and Auditingas part of the Global Qualityteam based in Bridgewater, NJ. Role OverviewThe Associate Director, GxP Compliance and Auditing, serves as the strategic leader for the development, implementation, and continuous enhancement of Legend Biotech's global GxP compliance and auditing programs. This role oversees all core elements of the compliance framework, including internal and externa audits, inspection readiness and logistics, ...

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  • 1 day ago

    Risk Assessment Specialist

    Legend Biotech USA - Raritan, NJ, United States

    Legend Biotech USA, Inc. seeks Risk Assessment Specialist in Raritan, NJ to: conduct Quality Risk Assessments (QRM per ICH Q9) for manufacturing processes, QC systems, and equipment, applying methodologies such as FMEA, HACCP, HAZOP, and Pareto analysis; develop, execute, and review validation master plans, cleaning validation, & method transfer protocols; prepare & review technical documentation; collaborate with QA, QC, Manufacturing, Engineering, and R&D teams; analyze data from risk assessments ...

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  • 1 day ago

    Sr Master Data Governance Specialist

    Legend Biotech USA - Raritan, NJ, United States

    Legend Biotech is seeking a Sr. Master Data Governance Specialistas part of the Technical Operationsteam based in Raritan, NJ. Role OverviewWe are actively seeking a proficient Sr. Master Data Governance Specialist with a specific focus on SAP Extended Warehouse Management (EWM) master data and materials orchestration throughout the End-to-End Manufacturing & Supply lifecycle. This role is pivotal in leading the design and execution of the Global Manufacturing & Supply (GMS) data governance ...

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  • 1 day ago

    Program Lead, Cell and Gene Therapy

    Legend Biotech USA - Raritan, NJ, United States

    Legend Biotech is seeking a Program Lead, Cell and Gene Therapyas part of the Global Manufacturing and Supplyteam based in Raritan, NJ.Role OverviewThe program Lead will be responsible for developing and executing the internal commercial manufacturing strategy for iLVV (in vivo Lentiviral Vector). This role will lead strategic planning, drive execution, propose options to senior leadership, of the commercial manufacturing introduction activities across late-stage and commercial programs, ensuring ...

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  • 5 days ago

    Sr. Manager, Clinical Trial Operations Planning & Analytics

    Legend Biotech USA - Somerset, NJ, United States

    Legend Biotech is seeking a Sr. Manager, Clinical Trial Operations Planning & Analyticsas part of the Clinical Operationsteam based in Somerset, NJ. Role OverviewThe Sr. Manager, Clinical Trial Operations Planning & Analytics is responsible for the strategic planning and analytics capability to support current and future Legend pipeline studies. This role will establish scalable approaches for feasibility, site identification, study startup planning, forecasting, and trial performance analytics ...

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  • 5 days ago

    Manager, Sample Management Operations

    Legend Biotech USA - Somerset, NJ, United States

    Legend Biotech is seeking a Manager, Sample Management Operationsas part of the Clinical Operationsteam based in Somerset, NJ. Role OverviewThe Sample Management Operations Manager is responsible for overseeing end-to-end sample management across Legend pipeline studies. The role strengthens visibility, accountability, and coordination across sites, CROs, central labs and specialty labs. Key ResponsibilitiesManage the operating model for sample management across current and future studies. ...

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  • 7 days ago

    Global Chief Medical Officer

    Legend Biotech USA - Somerset, NJ, United States

    Legend Biotech is seeking a Global Chief Medical Officer as part of the Clinical Development team based in Somerset, NJ.Role OverviewLegend Biotech is a global, integrated cell therapy company dedicated to discovering, developing, and manufacturing transformative therapies for patients with cancer, autoimmune, and other serious diseases. The company has a vision of harnessing the power of the immune system to create durable and potentially curative treatments. By combining deep scientific expertise ...

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  • 13 days ago

    QA Investigations Lead II

    Legend Biotech USA - Raritan, NJ, United States

    Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Investigation Lead is an exempt level position reporting to the QA Investigation Supervisor within the Raritan Investigation Excellence Team. The QA Investigations Lead is responsible for providing quality oversight and guidance during the investigation of events that occur in the production of a personalized cell therapy product in a sterile GMP environment. The ideal candidate ...

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  • 16 days ago

    Sr. QC Analyst

    Legend Biotech USA - Raritan, NJ, United States

    Legend Biotech is seeking a Sr. QC Analyst as part of the Quality team based in Raritan, NJ. Role OverviewThe Sr. QC Analyst is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment. Key ResponsibilitiesBe responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial ...

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