Immunogenicity & Immunoassay Scientist

Legendcareers

New Jersey

On-site

USD 96,000 - 126,000

Full time

5 days ago

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Benefits offered by this job

Medical, dental, vision insurance

401(k) match

Parental leave (8 weeks)

Paid time off

Well-being programs

Job summary

Legend Biotech is seeking a Scientist, Immunoassays to join the Bioanalytical team in Somerset, NJ. The role focuses on developing, qualifying, and validating bioanalytical assays for immunogenicity and ADA assessment in preclinical and clinical studies.

The candidate will work hands-on with ELISA, MSD, and Luminex platforms, analyze data, and prepare regulatory documents while ensuring GXP/GLP compliance. Collaboration across study teams is essential.

Qualifications

PhD or Master’s with substantial industry experience in immunoassays and biomarker work.
Hands-on ELISA, MSD, and Luminex assay development and validation experience.
Experience with non-clinical and clinical sample analysis in regulated environments.
Familiarity with FDA/ICH guidelines for Ligand Binding Immunoassays.
Proficiency with LIMS and ELN for sample logistics and documentation.
Ability to work in a cross-functional team supporting cell/gene therapy programs.
PPE required and safe handling of biological materials.
AI literacy with responsible use of tools and oversight.
Experience working in clinical, research, pharmaceutical, or diagnostic labs.

Responsibilities

Develop, qualify, and validate bioanalytical assays for immunogenicity and ADA assessment.
Analyze data and generate regulatory documentation.
Prepare validation plans, SOPs, reports and technical documents.
Coordinate sample management with LIMS and ELN; maintain chain of custody.
Collaborate across cross-functional teams to support timelines.