Scientist, Immunoassays

Role Overview

The Scientist, immunogenicity & Immunoassays is responsible for developing, qualifying, validating, and supporting bioanalytical assays used to assess immunogenicity and immune responses in preclinical and clinical studies. The successful candidate will have hands-on experience with Anti-Drug Antibody (ADA) assays, ELISAs, and other ligand-binding immunoassays and will contribute to assay development, method optimization, sample analysis, data interpretation, and regulatory documentation.

This position requires strong laboratory skills, scientific problem-solving abilities, and the capability to work collaboratively in a cross-functional environment supporting cell therapy, and gene therapy programs

Key Responsibilities

• Perform method development, qualification and validation for of soluble biomarker and immunogenicity (ADA) assays using ligand binding assay (ELISA, MSD and Luminex).
• Troubleshoot assay related issues with minimal guidance.
• Prepare and review assay protocols, validation plans, reports, SOP and technical documents.
• Data analysis using relevant analytical software.
• Perform routine laboratory responsibilities such as sample coordination, receiving and reconciliation using LIMS with maintaining adequate chain of custody and documentation.
• Use of ELN (electronic notebooks) to record laboratory work and for inventory management.
• Ensure the documentation and laboratory work is in compliance with GXP and GLP like regulatory environments.
• Ensure the assay qualification and validation are performed following the FDA, EMA and ICH guidelines.
• Collaborate with scientists, study managers, and cross-functional teams to support program timelines.
• Assist in method transfer and assay implementation activities.
• Participate in continuous improvement initiatives to enhance assay robustness and laboratory efficiency.
• Present scientific data at internal and external meetings.

Requirements

• 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 discipline with 6-8 years of relevant industry experience.
• 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.
• AI Literacy:
• Possesses a working knowledge of AI technologies and approved AI tools, applies them responsibly to enhance productivity and decision-making, exercises appropriate human oversight of AI-generated outputs, and complies with organizational policies governing AI use.

• #Li-RP1
• #Li-Onsite

Pay and benefits

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off

Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays.

Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.

We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay)

$96,267—$126,351 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.