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.