Scientist, Immunoassays

Legend Biotech•Somerset, NJ

43d•Onsite

About The Position

Legend Biotech is seeking a Scientist, Immunoassays as part of the Bioanalytical team based in Somerset, NJ. 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.

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 and validation for Immunogenicity assessment and biomarkers.
Work in a clinical, research, pharmaceutical, or diagnostic laboratory.
Use of personal protective equipment (PPE) is required.
Involve handling biological specimens and hazardous materials following safety guidelines.
AI Literacy: Possesses a working knowledge of AI technologies and approved AI tools, applies them responsibly to enhance productivity and decision-making, exercises appropriate human oversight of AI-generated outputs, and complies with organizational policies governing AI use.

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.

Benefits

Medical, dental, and vision insurance
401(k) retirement plan with a company match that vests fully on day one
Eight (8) weeks of paid parental leave after just three (3) months of employment
Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
Flexible spending and health savings accounts
Life and AD&D insurance
Short- and long-term disability coverage
Legal assistance
Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
Voluntary commuter benefits
Family planning and care resources
Well-being initiatives
Peer-to-peer recognition programs