Immunoassay Scientist - Immunogenicity & ADA

Legend Biotech US

New Jersey

On-site

USD 96,000 - 126,000

Full time

18 hours ago
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Benefits offered by this job

Medical insurance
401(k) retirement plan
Paid parental leave
Vacation and holidays

Job summary

Legend Biotech US, based in Somerset, NJ, is seeking a Scientist for the Bioanalytical team to develop and validate immunoassays to assess immunogenicity in preclinical and clinical studies. The role requires hands-on experience with ELISA, MSD, and Luminex platforms, plus strong data analysis and regulatory documentation skills.

The candidate will work cross-functionally in a regulated environment, maintaining SOPs and contributing to assay robustness and program timelines.

Qualifications

  • PhD or Master’s with required industry experience as described.
  • Hands-on experience with ELISA, MSD, and Luminex.
  • Familiarity with regulatory guidelines (FDA/ICH) for immunoassays.

Responsibilities

  • Develop, qualify, and validate soluble biomarker and ADA assays.
  • Analyze data with appropriate software and maintain documentation.
  • Prepare protocols, validation plans, and reports; ensure GLP/GXP compliance.
  • Collaborate cross-functionally to support program timelines.
  • Assist in method transfer and assay implementation activities.
  • Present data at internal/external meetings.

Skills

ELISA
MSD
Luminex
ADA assay development
Ligand-binding immunoassays
Data analysis
LIMS
ELN
GXP/GLP compliance
Regulatory documentation
AI literacy

Education

PhD in Biology/Immunology/Biochemistry/ Biotechnology/ Pharmaceutical Sciences
Master's degree in related field

Tools

LIMS
ELN
MSD platform
Luminex platform
ELISA

Job description

Legend Biotech US, based in Somerset, NJ, is seeking a Scientist for the Bioanalytical team to develop and validate immunoassays to assess immunogenicity in preclinical and clinical studies. The role requires hands-on experience with ELISA, MSD, and Luminex platforms, plus strong data analysis and regulatory documentation skills.

The candidate will work cross-functionally in a regulated environment, maintaining SOPs and contributing to assay robustness and program timelines.

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