Fengqiang W

A highly motivated Ph.D. scientist with more than 10 years of in-depth scientific knowledge, strong technical skills, and proven leadership in oncology research and biopharmaceutical development. - Strong experience with the analytical (HPLC, LC-MS/MS) and bio-analytical (immunoassay, chromogenic assay) method development, transfer, qualification, and validation for process-residuals testing at contract research organization (CRO) or in house. - Comprehensive experience with the process characterization and validation of process-related impurities clearance during biopharmaceutical downstream processing. - Strong expertise and hands-on experience in host cell protein (HCP) immunoassay development and HCP characterization by 2D-PAGE/2D-Western blot, 2D-DIGE, and 2D-LC-MS. - Extensive experience in technical writing, including the authoring and reviewing of research grant proposals, CMC regulatory filings supporting documents and the IND and BLA filing documents. - Familiar with QbD concept for analytical method development and hands-on experience of using DoE approach for immunoassay development. - Experience with biosimilar drug development, especially on the analytical characterization and similarity evaluation. - More than 10 years of academic research experience on cancer pharmacology and cancer biology with a deep understanding of tumor microenvironment and immunotherapies targeting the immunomodulatory receptors (IMR) on T-cells. - Excellent problem-solving skills and leadership skills on strategic planning and project timeline management with a proven record of getting things done in a timely manner. - Strong team leadership skills, communication skills and interpersonal skills with a proven record of leading high performance teams.