Immunogenicity & Immunoassays Scientist (ELISA/ADA)

BioNJ Inc.; New Jersey; On-site; USD 110,000 - 160,000; Full time

Job summary

Legend Biotech is seeking a Scientist, Immunoassays for the Bioanalytical team in Somerset, NJ. The role focuses on developing, qualifying, validating, and supporting bioanalytical assays to assess immunogenicity in preclinical and clinical studies, with hands-on work on ADA, ELISA, MSD, and Luminex platforms.

The candidate will interpret data, prepare regulatory documents, transfer methods, and collaborate cross-functionally to support cell therapy programs while ensuring GXP/GLP compliance and

Qualifications

• PhD or master's with required years as stated.
• Hands-on experience with ELISA and MSD/Luminex platforms.
• Experience with biomarker and ADA assay development and validation.
• Experience in regulated environments (FDA/ICH) and use of LIMS/ELN.
• Ability to work in cross-functional teams and present data.

Responsibilities

• Perform method development, qualification and validation for ADA and biomarker assays (ELISA, MSD, Luminex).
• Troubleshoot assay issues with minimal guidance.
• Prepare and review protocols, validation plans, reports, and SOPs.
• Analyze data using analytical software.
• Coordinate samples and maintain chain of custody using LIMS and ELN.
• Record work and manage inventory in electronic notebooks.
• Ensure compliance with GXP/GLP regulatory environments.
• Follow FDA, EMA, and ICH guidelines for assay qualification and validation.
• Collaborate with cross-functional teams to meet program timelines.
• Assist in method transfer and assay implementation.
• Contribute to continuous improvement for robustness and efficiency.
• Present scientific data at meetings.

Skills

ELISA

Luminex

ADA assay development

Bioanalytical problem-solving

Team collaboration

Data analysis

Education

PhD in Biology, Immunology, Biochemistry, Biotechnology, Pharmaceutical Sciences, or related field

Master's degree in related field with 6-8 years experience

Tools

LIMS

ELN

MSD

Job description

Legend Biotech is seeking a Scientist, Immunoassays for the Bioanalytical team in Somerset, NJ. The role focuses on developing, qualifying, validating, and supporting bioanalytical assays to assess immunogenicity in preclinical and clinical studies, with hands-on work on ADA, ELISA, MSD, and Luminex platforms.

The candidate will interpret data, prepare regulatory documents, transfer methods, and collaborate cross-functionally to support cell therapy programs while ensuring GXP/GLP compliance and