Scientist, Immunoassays

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 a Scientist, Immunoassays as part of the Bioanalytical team based in Somerset, NJ.

Role Overview

The Scientist, immunogenicity & Immunoassays is responsible for developing, qualifying, validating, and supporting bioanalytical assays used to assess immunogenicity and immune responses in preclinical and clinical studies. The successful candidate will have hands‑on experience with Anti‑Drug Antibody (ADA) assays, ELISAs, and other ligand‑binding immunoassays and will contribute to assay development, method optimization, sample analysis, data interpretation, and regulatory documentation.

This position requires strong laboratory skills, scientific problem‑solving abilities, and the capability to work collaboratively in a cross‑functional environment supporting cell therapy, and gene therapy programs

Key Responsibilities

• Perform method development, qualification and validation for of soluble biomarker and immunogenicity (ADA) assays using ligand binding assay (ELISA, MSD and Luminex).
• Troubleshoot assay related issues with minimal guidance.
• Prepare and review assay protocols, validation plans, reports, SOP and technical documents.
• Data analysis using relevant analytical software.
• Perform routine laboratory responsibilities such as sample coordination, receiving and reconciliation using LIMS with maintaining adequate chain of custody and documentation.
• Use of ELN (electronic notebooks) to record laboratory work and for inventory management.
• Ensure the documentation and laboratory work is in compliance with GXP and GLP like regulatory environments.
• Ensure the assay qualification and validation are performed following the FDA, EMA and ICH guidelines.
• Collaborate with scientists, study managers, and cross‑functional teams to support program timelines.
• Assist in method transfer and assay implementation activities.
• Participate in continuous improvement initiatives to enhance assay robustness and laboratory efficiency.
• Present scientific data at internal and external meetings.

Requirements

• PhD in Biology, Immunology, Biochemistry, Biotechnology, Pharmaceutical Sciences, or related scientific field with 0-3 years of relevant industry experience.
  OR
• Master's degree in a related scientific discipline with 6-8 years of relevant industry experience.
• Hands‑on experience with ELISA assay and MSD (Meso Scale Discovery) and Luminex platform.
• 2-6 years of hands‑on experience with biomarker and ADA assay development and validation.
• Experience with non‑clinical and clinical sample analysis in a regulated environment.
• Use of LIMS and ELN for sample logistics and documentation.
• Solid understanding of FDA and ICH guidelines for Ligand Binding Immunoassay qualification…