Scientist, Immunoassays

BioNJ Inc.; New Jersey; On-site; USD 110,000 - 160,000; Full time

Job summary

Legend Biotech is seeking a Scientist, Immunoassays for the Bioanalytical team in Somerset, NJ. The role focuses on developing, qualifying, validating, and supporting bioanalytical assays to assess immunogenicity in preclinical and clinical studies, with hands-on work on ADA, ELISA, MSD, and Luminex platforms.

The candidate will interpret data, prepare regulatory documents, transfer methods, and collaborate cross-functionally to support cell therapy programs while ensuring GXP/GLP compliance and

Qualifications

• PhD or master's with required years as stated.
• Hands-on experience with ELISA and MSD/Luminex platforms.
• Experience with biomarker and ADA assay development and validation.
• Experience in regulated environments (FDA/ICH) and use of LIMS/ELN.
• Ability to work in cross-functional teams and present data.

Responsibilities

• Perform method development, qualification and validation for ADA and biomarker assays (ELISA, MSD, Luminex).
• Troubleshoot assay issues with minimal guidance.
• Prepare and review protocols, validation plans, reports, and SOPs.
• Analyze data using analytical software.
• Coordinate samples and maintain chain of custody using LIMS and ELN.
• Record work and manage inventory in electronic notebooks.
• Ensure compliance with GXP/GLP regulatory environments.
• Follow FDA, EMA, and ICH guidelines for assay qualification and validation.
• Collaborate with cross-functional teams to meet program timelines.
• Assist in method transfer and assay implementation.
• Contribute to continuous improvement for robustness and efficiency.
• Present scientific data at meetings.

Skills

ELISA

Luminex

ADA assay development

Bioanalytical problem-solving

Team collaboration

Data analysis

Education

PhD in Biology, Immunology, Biochemistry, Biotechnology, Pharmaceutical Sciences, or related field

Master's degree in related field with 6-8 years experience

Tools

LIMS

ELN

MSD

Job description

Legend Biotech is seeking a Scientist, Immunoassays as part of the Bioanalytical team based in Somerset, NJ.

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

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

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

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

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