Immunoassays Scientist: ADA & ELISA Specialist

Legend Biotech, Inc.; New Jersey; On-site; USD 96,000 - 126,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid parental leave

Job summary

Legend Biotech, Inc. seeks a Scientist, Immunoassays in Somerset, NJ, to develop and validate bioanalytical assays for immunogenicity and immune responses in preclinical/clinical studies. Hands-on ADA/ligand-binding assays and data interpretation are required.

The role emphasizes跨-functional teamwork in a regulated environment, with strong lab skills and FDA/ICH guideline knowledge. E‑Verify participation is noted.

Qualifications

• PhD in Biology, Immunology, Biochemistry, Biotechnology, Pharmaceutical Sciences, or related field with 0–3 years of industry experience.
• Or Master's degree with 6–8 years of relevant industry experience.
• Hands-on ELISA, MSD, and Luminex assay experience.
• 2–6 years of biomarker and ADA assay development/validation.
• Experience with regulated clinical/non-clinical samples.
• Familiarity with LIMS/ELN for logistics and documentation.
• Solid understanding of FDA/ICH guidelines for ligand-binding immunoassay qualification/validation, Immunogenicity assessment.

Responsibilities

• Perform method development, qualification and validation for soluble biomarker and immunogenicity assays (ELISA, MSD, Luminex).
• Troubleshoot assay issues with minimal guidance.
• Prepare and review assay protocols, validation plans, reports, SOPs and technical documents.
• Data analysis using relevant analytical software.
• Coordinate samples and reconcile using LIMS with custody and documentation.
• Record work in ELN and manage inventory.
• Ensure documentation complies with GXP/GLP-like regulatory environments.
• Ensure assay qualification/validation follows FDA/EMA/ICH guidelines.
• Collaborate with scientists and cross-functional teams to support timelines.
• Assist in method transfer and assay implementation.
• Participate in continuous improvement to enhance assay robustness and efficiency.
• Present scientific data at internal and external meetings.

Skills

ELISA

MSD

Luminex

ADA assays

Ligand-binding IA

Data analysis

AI literacy

Cross-functional teamwork

Education

PhD in biology/immunology/biotech

Master's in related field

Tools

LIMS

ELN

Job description

Legend Biotech, Inc. seeks a Scientist, Immunoassays in Somerset, NJ, to develop and validate bioanalytical assays for immunogenicity and immune responses in preclinical/clinical studies. Hands-on ADA/ligand-binding assays and data interpretation are required.

The role emphasizes跨-functional teamwork in a regulated environment, with strong lab skills and FDA/ICH guideline knowledge. E‑Verify participation is noted.