Scientist, Immunoassays

The role

The Scientist, Immunoassays will develop, qualify, validate, and support bioanalytical assays to assess immunogenicity and immune responses in preclinical and clinical studies. This role involves assay development, method optimization, sample analysis, and data interpretation.

What you will do

• Perform method development, qualification and validation for soluble biomarker and immunogenicity (ADA) assays using ELISA, MSD and Luminex.
• Troubleshoot assay related issues with minimal guidance.
• Prepare and review assay protocols, validation plans, reports, SOP and technical documents.
• Perform data analysis using relevant analytical software.
• Perform routine laboratory responsibilities such as sample coordination, receiving and reconciliation using LIMS.
• Use ELN to record laboratory work and for inventory management.
• Ensure documentation and laboratory work is in compliance with GXP and GLP like regulatory environments.
• Ensure assay qualification and validation follow FDA, EMA and ICH guidelines.
• Collaborate with scientists, study managers, and cross-functional teams.
• Assist in method transfer and assay implementation activities.

Required qualifications

• PhD in Biology, Immunology, Biochemistry, Biotechnology, Pharmaceutical Sciences, or related scientific field with 0-3 years of relevant industry experience OR Master's degree in a related scientific
• Hands-on experience with ELISA assay and MSD (Meso Scale Discovery) and Luminex platform.
• 2-6 years of hands-on experience with biomarker and ADA assay development and validation.
• Experience with non-clinical and clinical sample analysis in a regulated environment.
• Use of LIMS and ELN for sample logistics and documentation.
• Solid understanding of FDA and ICH guidelines for Ligand Binding Immunoassay qualification and validation for Immunogenicity assessment and biomarkers.
• Work in a clinical, research, pharmaceutical, or diagnostic laboratory.
• Use of personal protective equipment (PPE) is required.
• Involve handling biological specimens and hazardous materials following safety guidelines.
• Working knowledge of AI technologies and approved AI tools.

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement plan with a company match that vests fully on day one
• Eight (8) weeks of paid parental leave after three (3) months of employment
• Paid time off including vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
• Flexible spending and health savings accounts
• Life and AD&D insurance
• Short- and long-term disability coverage
• Legal assistance
• Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
• Voluntary commuter benefits
• Family planning and care resources
• Well-being initiatives and peer-to-peer recognition programs

Before you apply

• Applicants must be authorized to work in the United States.
• Employment eligibility will be verified through E-Verify.

About the company

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, the company advances cell therapy through a portfolio of innovative technologies.