• Dedicated biopharmaceutical professional with over 20 years of drug development experience in a broad range of products including monoclonal antibodies, gene therapy, and cell therapy products for oncology, autoimmunity, and neurological disorders. • Proven success and leadership in developing phase-appropriate analytical methods to support pre-clinical studies and clinical trials, including cell-based assays, ligand binding assays, ELISA, flow cytometry, qPCR, cell cytotoxicity and other assays. Strong expertise in assay development, qualification, and validation, in-depth understanding of FDA/ICH/USP/EP regulatory requirements. Extensive experiences working with CROs for analytical method transfer, vendor selection, vendor oversight and assay troubleshooting. • As head of Quality Control in a GMP biomanufacturing facility (CDMO), successfully managed the release testing of 300+ lots of GMP products and their stability testing to support Phase I-III clinical trials. Developed release testing strategy and stability testing strategy of numerous types of biologics to support their regulatory filing. • Effectively build and lead a high-performance team of Ph.D scientists and senior research associates and ensure timely delivery of goals against aggressive timelines. Effectively lead multiple projects simultaneously. Excellent analytical skills and troubleshooting capabilities to resolve issues immediately. • Proactive team player, working closely with cross-functional teams and stakeholders to deliver project goals in a timely manner. Strong communication and interpersonal skills.Expertise:Drug development, monoclonal antibodies, cell therapy products, gene therapy products, CMC, bioanalytical development strategies, assay development, qualification, and validation, GMP manufacturing, product release, release testing and stability testing strategies, Quality Control