Dr. Claudia LinGeneral Manager
林巧博士，中国第十二届千人计划企业创新专家，苏州工业园区双创A级领军人物。林博士出生于上海，曾就学于复旦大学，获美国加州大学伯克利分校细胞和分子生物学博士学位。在博士后培训期间及之后，林博士对基础型和转化型癌症进行深入研究。过去15年里，她的职业生涯主要聚焦于化学、生产和控制以及质量等方面。她曾在基因泰克/罗氏上任多种质量领导岗位，包括临床研发QA和QC部门，以及罗氏全球商业化生物产品技术转移、年度产品质量回顾等；之后在加州的拜耳医药生物技术分部担任质量总监，全面负责所有临床开发中的产品的质量体系及产品质量。曾参与全球领先的单抗产品上市工作。林博士在欧美同行中享有很好的声誉，活跃与世界级的专业会议讲台。林博士于2015年初从美归国，曾担任一家中国知名生物制药企业副总裁，负责GMP合规与质量管理。自2016年9月起，林博士担任江苏康宁杰瑞生物制药有限公司总经理一职。 Dr. Claudia Lin is a China 1000 Innovation Talent Award recipient, and an Innovation and Entrepreneur Leadership Award recipient at SIP. She was born and raised in Shanghai and went to Fudan University. She then went to the US and obtained her Ph.D degree in Cell and Molecular Biology from University of California at Berkeley. During and after her post-doctoral training, she conducted basic and translational research in cancer and other diseases areas. For the past 15 years, her career has been focused on CMC, manufacturing and Quality. Dr. Lin held various Quality leadership positions in Genentech/ROCHE including QA and QC functions for clinical development, as well as technology transfer and Annual Product Quality Review for ROCHE global commercial biologics portfolio. Afterwards, she was head of Quality Assurance for Bayer Healthcare Biotech division in California, responsible for all products in clinical development. She was also involved in the work of global leading monoclonal antibody products listing. Dr. Lin is a reputable biotech Quality professional in the US and in Asia and is a regular speaker in international conferences. When Dr. Lin first came back to China in early 2015, she worked as Vice President at another leading biopharma in China, responsible for GMP compliance and Quality management. In order to broaden her influence and impact on China Biotechnology industry, Dr. Lin took on the position of General Manager, Alphamab (Jiangsu) since September 2016.
10:00 AM Effective Biopharma Quality Management and Standardisation at all stages - from Research and Development through to Manufacturing and Distribution | 整合统一各环节的质量管理高标准——从研发、生产到配送
Ø Establishing quality standards to ensure optimal life cycle management
Ø Quality by Design (QBD): Necessitating the investment in quality risk management upfront in the research and development stage of a product
Ø Infrastructure design and preparation for consistent quality delivery