发布时间:
2022
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11
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24
点击次数:
0
所属职位：
工艺开发和CMC策略执行总监
所属公司：
信达生物制药（苏州）有限公司
个人简介：
Dr. Sun Chau Siu is currently Head of Process Development and CMC Strategy at Innovent Biologics. He has broad responsibilities in overseeing cell line development, process design and characterization, clinical manufacturing, and building a global CMC platform. Dr. Siu has over 20 years of international experience in the biopharmaceutical industry, with rich knowledge in GMP manufacturing, validation, MSAT, tech transfer, regulatory, CMC development, and process development. Before Innovent, he had worked at Genentech (USA). His professional experience also includes Roche (Singapore), Pfizer (UK), and Sanofi Pasteur (Canada). Among his experience, he played critical roles in the start-up of two biologics facilities, led multiple process tech transfers, successfully obtained health authority application approvals, and supported numerous health authority GMP/PAI/PLI inspections.Dr. Siu has a Ph.D. and MSc in Biochemical Engineering from University College London, UK, and a BSc (Hons) in Biochemistry and Chemistry from The University of British Columbia, Canada. He also obtained an executive MBA from Rutgers University, USA, and is a certified Project Management Professional (PMP).萧新洲博士现任信达生物工艺开发部和CMC策略部执行总监。统管细胞株开发、上下游工艺开发和表征、临床样品生产和全球化的CMC平台构建。萧博士在生物制药行业拥有20余年的国际化从业经验，从业内容涉及GMP生产、MSAT、注册、CMC平台建设和工艺开发。在加盟信达生物之前，他曾在Genentech (美国) 工作。此外还曾在罗氏 (新加坡) 、辉瑞 (英国) 和赛诺菲 (加拿大)工作过。他曾作为关键成员参与了两个生物药生产厂房的建设，领导多个项目的工艺技术转移，成功获得监管机构的批准，并支持了大量的GMP/PAI/PLI审计活动。萧博士拥有英国伦敦大学的生化工程博士学位和硕士学位，以及加拿大不列颠哥伦比亚大学的生物化学和化学学士学位。并获得了美国罗格斯大学的工商管理硕士学位，以及项目管理专业人员 (PMP)认证。