Immunogenicity & ADA Immunoassay Scientist
Legend Biotech EU
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Benefits offered by this job
Job summary
Legend Biotech is seeking a Scientist, Immunoassays in Somerset, NJ to develop, qualify, validate, and support bioanalytical assays for immunogenicity in preclinical and clinical studies. Strong ADA/biomarker assay experience and cross-functional collaboration are required.
The role involves hands‑on work with ELISA, MSD, and Luminex platforms, data interpretation, and regulatory documentation in a GMP/GxP‑like environment.
Qualifications
- Hands-on ELISA, MSD and Luminex assay experience.
- 2-6 years of biomarker and ADA assay development/validation.
- Experience with clinical/non-clinical samples in a regulated environment.
- LIMS and ELN usage for sample logistics and documentation.
- Strong knowledge of FDA/ICH guidelines for ligand-binding immunoassay qualification and validation.
Responsibilities
- Develop, qualify, validate bioanalytical assays for immunogenicity.
- Analyze data and prepare reports and technical documents.
- Coordinate sample management and documentation using LIMS/ELN.
- Support method transfer and assay implementation across programs.
- Collaborate with cross-functional teams to meet timelines.
Skills
Education
Tools
Job description
Legend Biotech is seeking a Scientist, Immunoassays in Somerset, NJ to develop, qualify, validate, and support bioanalytical assays for immunogenicity in preclinical and clinical studies. Strong ADA/biomarker assay experience and cross-functional collaboration are required.
The role involves hands‑on work with ELISA, MSD, and Luminex platforms, data interpretation, and regulatory documentation in a GMP/GxP‑like environment.
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