阙博士,和铂医药首席技术官,负责CMC版块,工艺开发,GMP临床样品生产与商业化生产,推动管线项目的研发与上市。成功领导、参与多个抗体药与蛋白药的开发与上市,在生物药研发、CMC 、蛋白分析与特征研究、质量体系、质量控制、GMP临床与商业化生产,技术平台建设、团队建设、项目管理、法规注册方面具有20多年的丰富经验。 加入和铂医药之前,阙红博士曾任职于美国辉瑞制药及基因泰克科学家与首席科学家,药明生物执行主任,信达生物制药集团高级副总裁。 阙博士获得美国印第安纳大学分析化学博士学位。 Dr. Que serves as Chief Technology Officer at Harbour BioMed, responsible for CMC development including process development, cGMP manufacturing of antibody therapeutics. She is specialized at Analytical Development and Quality Control, and She has extensive experience in leading projects through CMC development, IND filing, clinical development, BLA/NDA filing, GMP/PAI inspection towards BLA approval, product launch and commercialization. Previously, Dr. Que worked as Senior VP of Quality for Innovent Biologics, Executive Director of Protein Analytical Science for WuXi Biologics, Genentech and Pfizer Global Biologics in the area of protein analytical chemistry of protein drug development. Dr. Que obtained PhD in Bioanalytical Chemistry from Chemistry Department, Indiana University. |