Immunogenicity & Immunoassay Scientist

HireLifeScience; New Jersey; On-site; USD 96,000 - 126,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

8 weeks of paid parental leave

Paid time off and holidays

Commuter benefits

Job summary

Legend Biotech in Somerset, NJ seeks a Scientist, Immunoassays to develop, qualify, validate, and support bioanalytical assays for immunogenicity and responses in preclinical and clinical studies.

You will work hands-on with ADA assays, ELISAs, MSD and Luminex, contribute to data interpretation, regulatory documentation, and cross-functional collaboration in cell and gene therapy programs.

Qualifications

• PhD in Biological sciences with 0–3 years industry experience or
• Master's with 6–8 years industry experience.
• Hands-on ELISA, MSD, and Luminex platform experience.
• 2–6 years biomarker and ADA assay development and validation.
• Experience with non-clinical/clinical samples in regulated environments.
• LIMS and ELN documentation experience.
• Strong knowledge of FDA/ICH guidelines for ligand-binding immunoassays.
• AI Literacy: working knowledge of AI tools with responsible use.

Responsibilities

• Develop, qualify and validate soluble biomarker and immunogenicity (ADA) assays (ELISA, MSD, Luminex).
• Troubleshoot assay issues with minimal guidance.
• Prepare and review protocols, validation plans, reports, SOPs, and technical documents.
• Data analysis using relevant analytical software.
• Coordinate samples and maintain documentation in LIMS/ELN with chain-of-custody.
• Record laboratory work using ELN and manage inventory.
• Ensure compliance with GXP/GLP-like regulatory environments and FDA/ICH guidelines.
• Collaborate with scientists and study managers to support program timelines.
• Assist in method transfer and assay implementation.
• Contribute to continuous improvement and present data internally.

Skills

ELISA

MSD

Luminex

ADA assays

Immunogenicity

Data analysis

Regulatory compliance

Cross-functional collaboration

Education

PhD in Biology/Immunology/Biochemistry/Biotech/Pharmaceutical Sciences

Master's in related science with 6-8 years experience

Tools

LIMS

ELN

ELISA platform

MSD

Luminex platform

Job description

Legend Biotech in Somerset, NJ seeks a Scientist, Immunoassays to develop, qualify, validate, and support bioanalytical assays for immunogenicity and responses in preclinical and clinical studies.

You will work hands-on with ADA assays, ELISAs, MSD and Luminex, contribute to data interpretation, regulatory documentation, and cross-functional collaboration in cell and gene therapy programs.