Scientist, Immunoassays

Role: Scientist, Immunoassays within the Bioanalytical team focusing on developing and supporting bioanalytical assays for immunogenicity and immune responses in preclinical and clinical cell/gene therapy studies. Responsibilities: perform assay development, qualification, validation (e.g., ADA, ELISA, MSD, Luminex), troubleshoot, prepare technical documentation, analyze data, and ensure compliance with GxP/GLP standards aligned with FDA, EMA, and ICH guidelines. Collaborate cross-functionally with study teams and support assay transfer and continuous improvement initiatives. Requirements: PhD in Biology, Immunology, or related field with 0-3 years or Master’s with 6-8 years of relevant industry experience; hands-on expertise with immunoassays, biomarker development, and validation; experience with regulated environments, LIMS, ELN, and regulatory compliance. Preferred: familiarity with clinical sample analysis, AI tools, and lab safety protocols. High-Value: focus on immunogenicity assessment in cell and gene therapy programs, supporting early to late-stage clinical studies. Work setup: based in Somerset, NJ, with laboratory responsibilities involving biological specimens handling.