Senior Scientist, Analytical Development (FFBA)

Role: Senior Scientist, Analytical Development (FFBA) supporting cell and gene therapy programs at Legend Biotech, focusing on assay development, qualification, and transfer to support clinical manufacturing. Responsibilities: develop and optimize analytical methods including flow cytometry, immunoassays, and bioanalytical assays for CAR-T and viral vector products; lead method qualification, transfer, and validation activities; author technical documentation; collaborate cross-functionally with QC, PD, and manufacturing; ensure compliance with GxP and regulatory standards; mentor junior scientists and contribute to scientific decision-making. Requirements: PhD or Master in immunology, cell biology, biomedical engineering; 5-10 years in analytical method development in biotech/pharma, with expertise in biologics, viral vectors, and cell therapy assays; strong understanding of ICH guidelines, GxP, and regulatory expectations; experience in assay qualification, comparability, and late-stage development preferred. HighValue: cell/gene therapy, CAR-T, viral vectors, assay qualification, GxP, IND/BLA support, cross-functional collaboration. WorkSetup: based in Somerset, NJ, with a focus on supporting clinical-grade manufacturing activities.