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
  • 2 days ago

    Sr. Manager, QC Microbiology

    Legend Biotech USA - Raritan, NJ, United States

    Legend Biotech is seeking a Sr. Manager, QC Microbiologyas part of the Quality team based inRaritan, NJ.Role OverviewThe Sr. Manager, QC Microbiology, is an exempt level position with responsibilities for managing the operation and workflow of the quality control microbiology laboratories in support of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data, developing and implementing microbiology procedures ...

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  • 13 days ago

    QA, Shop Floor Specialist II

    Legend Biotech USA - Raritan, NJ, United States

    Legend Biotech is seeking a QA Shop Floor Specialistas part of the Qualityteam based in Raritan, NJ.Role OverviewThe QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable ...

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  • 13 days ago

    Director, QA Operations

    Legend Biotech USA - Raritan, NJ, United States

    Legend Biotech is seeking a Director, QA Operationsas part of the Qualityteam based in Raritan, NJ.Role Overview The Director of Quality Operations, CAR-T is responsible for Quality oversight and support of cell therapy manufacturing operations, in full compliance with established cGMP requirements. Functions and activities include Disposition activities, including incoming materials and final drug product, QA shop floor oversight of manufacturing operations, Quality Assurance review and approval ...

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  • 15 days ago

    Sr. Manager Quality IT

    Legend Biotech USA - Bridgewater, NJ, United States

    Legend Biotech is seeking aSr Manager, Quality ITas part of the Quality ITteam based in Bridgewater, NJ.Role OverviewThe Sr Manager, Quality IT is responsible for providing IT Quality oversight for the implementation and lifecycle management of GxP IT systems within Legend Biotech. Duties include, but are not limited to interpreting applicable regulations, defining IT QA requirements and implementing processes and procedures at Legend that comply with regulatory guidelines and company standards. ...

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  • 15 days ago

    Sr. MES Engineer

    Legend Biotech USA - Raritan, NJ, United States

    Legend Biotech is seeking aSr. MES Engineeras part of the Manufacturing & Supplyteam based inRaritan, NJ. Role OverviewThe Senior MES Engineer will be a driving member of the Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for independently driving and performing EBR development and administration at the Raritan site to support production processing while managing interactions with other functions including but not limited to Tech ...

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  • 15 days ago

    Investigations Supervisor

    Legend Biotech USA - Raritan, NJ, United States

    Legend Biotech is seeking an Investigations Supervisoras part of the Manufacturing & Supplyteam based in Raritan, NJ. Role OverviewThe CAR -T Investigation Supervisor will work with the investigation team to help identify true root cause of investigations and assess product quality impact. This individual will provide technical support to the investigators and resolution of deviations and atypical events. They will recommend, own, and implement corrective/preventative measures aimed at improving ...

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  • 16 days ago

    Supervisor, QC Microbiology

    Legend Biotech USA - Raritan, NJ, United States

    Legend Biotech is seeking a Supervisor, QC Microbiologyas part of the Quality Operationsteam based in Raritan, NJ. Role OverviewThe Supervisor, QC Micro is an exempt level position with responsibilities for supervising the operation and workflow of the quality control microbiology laboratories in support of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data, developing and implementing microbiology ...

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  • 16 days ago

    Sr. Sourcing & Procurement Specialist

    Legend Biotech USA - Raritan, NJ, United States

    Legend Biotech is seeking a Sr. Sourcing & Procurement Specialistas part of the Manufacturing &Supply team based in Raritan, NJ. Role OverviewThe Senior Sourcing & Procurement Specialist supports procurement activities across Legend Biotech's U.S. business units, with primary support for the Raritan, NJ site. This role supports timely and compliant purchasing execution, supplier onboarding, commercial review, contract workflow support, and resolution of purchasing-related issues in alignment ...

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  • 17 days 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 ...

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  • 17 days ago

    IT Validation Specialist

    Legend Biotech USA - Somerset, NJ, United States

    Legend Biotech is seeking anIT Validation Analystas part of the R&D Systemsteam based in Somerset, NJ. Role OverviewThe IT Validation Analyst is responsible for supporting and executing validation activities for GxP-regulated computerized systems. This role ensures systems are implemented, maintained, and operated in compliance with regulatory requirements and company procedures. The analyst works closely with IT, Quality Assurance, Business Process Owners, and vendors to ensure validated systems ...

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