Position Summary:

The Senior Research Associate- Immunoassay Development, will support the development, optimization, qualification/validation, and execution of immunogenicity assays for AAV gene therapy programs. This role will focus on total antibody and cell-based neutralizing antibody assays across multiple AAV serotypes and will support nonclinical and clinical sample analysis, data review, and study documentation in a regulated laboratory environment. This laboratory-based position offers opportunities to expand expertise in cell biology, immunology, bioanalysis, and the interpretation of clinical immunology data.

Job Responsibilities

• Develop, optimize, qualify, and validate binding antibody assays against proteins of interest in support of nonclinical and clinical gene therapy programs, with an emphasis on ligand-binding immunoassays such as ELISA and MSD platforms.

• Develop, optimize, qualify, and validate total antibody and cell-based neutralizing antibody assays for AAV vectors, including screening, confirmatory, and titration approaches, as appropriate.

• Troubleshoot experimental protocols to ensure accuracy, reproducibility, and efficiency.

• Support nonclinical and clinical sample analysis in accordance with applicable GLP, GCLP, GCP, SOP, and study-specific requirements while applying technical expertise in mammalian cell culture, ligand-binding assays, and cell-based immunoassays.

• Document laboratory activities contemporaneously and accurately in accordance with applicable SOPs and data-integrity requirements, including sample preparation, assay execution, instrument use, data review, deviations, and investigations.

• Author, review, and revise study protocols, assay qualification and validation reports, sample-analysis reports, standard operating procedures, work instructions, assay-transfer documents, and technical summaries supporting project and regulatory objectives.

• Support laboratory operations through reagent preparation and inventory management, sample and critical-reagent tracking, equipment maintenance and calibration coordination, laboratory organization, and adherence to environmental health and safety requirements.

• Analyze assay data, evaluate run acceptance criteria and quality-control performance, identify trends or atypical results, and promptly communicate findings to project teams.

• Present summaries of findings at team meetings and to stakeholders, as needed.

• Collaborate with Bioanalytical Sciences, Clinical Operations, Quality, Regulatory Affairs, and external laboratories to support assay transfer, study execution, issue resolution, and the timely delivery of high-quality data.

Minimum Requirements

• Bachelor’s degree in immunology, cell biology, molecular biology, or a related scientific discipline, with 5+ years of relevant laboratory experience in the biotechnology or pharmaceutical industry

• Hands-on experience developing, qualifying, validating, or executing immunoassays in a biotechnology, pharmaceutical, contract research, or regulated laboratory environment.

• Experience with mammalian cell culture and aseptic technique

• Experience with cell-based viral neutralization assays and binding antibody assays

• Demonstrated experience using aseptic technique and following biosafety practices in a Biosafety Level 2 laboratory

• Strong attention to detail and the ability to collaborate effectively in a team environment

• Proficiency in Microsoft Word, Excel, and PowerPoint, with experience using data-analysis software such as GraphPad Prism or JMP to review, visualize, and communicate assay results

• Demonstrated ability to organize and prioritize laboratory work, manage multiple assignments, work independently with appropriate guidance, and contribute effectively within cross-functional teams

• Strong written and verbal communication skills, including the ability to document methods and results clearly, present scientific findings, raise issues promptly, and collaborate effectively with internal teams and external partners

Preferred Education, Experience, and Skills

• Master’s degree in immunology, cell biology, biochemistry, molecular biology, or a related scientific discipline

• Experience with AAV binding antibody or neutralizing antibody assays.

• Knowledge of companion diagnostics

• Experience in performing Western blotting and protein labeling or purification

• Experience processing primary cells isolated from peripheral blood

• Experience working under GLP or GCLP requirements i

• Experience testing clinical samples