Immunogenicity & Immunoassays Scientist
Legend Biotech US
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Benefits offered by this job
Job summary
Legend Biotech is seeking a Scientist, Immunoassays in the Bioanalytical team based in Somerset, NJ. The role develops, qualifies, validates immunogenicity and ADA assays (ELISA, MSD, Luminex) for preclinical and clinical studies.
You will work in cross-functional teams, interpret data, prepare regulatory documents, and ensure compliant operations under GXP/GLP; a PhD or MS with relevant experience required.
Qualifications
- PhD in Biology/Immunology/biotech with 0–3 years industry experience OR
- MS in related field with 6–8 years industry experience.
- Hands-on ELISA, MSD, and Luminex experience.
- 2–6 years in biomarker and ADA assay development/validation.
- Experience with regulated clinical/non-clinical samples.
- Familiarity with FDA/ICH guidelines for ligand-binding immunoassays.
- Able to work in a cross-functional team; PPE compliant.
Responsibilities
- Develop, qualify, and validate immunogenicity and ADA assays (ELISA, MSD, Luminex).
- Troubleshoot assay issues with minimal guidance.
- Prepare/Review protocols, validation plans, reports, SOPs.
- Analyze data with appropriate software.
- Coordinate samples using LIMS; maintain chain of custody and documentation.
- Record work in ELN; ensure GXP/GLP compliant operations.
- Support method transfer and assay implementation.
- Present data at internal/external meetings.
Skills
Education
Tools
Job description
Legend Biotech is seeking a Scientist, Immunoassays in the Bioanalytical team based in Somerset, NJ. The role develops, qualifies, validates immunogenicity and ADA assays (ELISA, MSD, Luminex) for preclinical and clinical studies.
You will work in cross-functional teams, interpret data, prepare regulatory documents, and ensure compliant operations under GXP/GLP; a PhD or MS with relevant experience required.
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