Dr. Claudia Lin PhDFounder & CEO
AABioQM, (Suzhou) Jiayu Biomedical
林巧博士，中组部第十二批千人计划创新专家，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，之后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过深入研究。在过去15年里，她的职业生涯主要聚焦于化学、生产和控制尤其是质量管理等方面。她曾在基因泰克/罗氏担任多种质量管理领导的岗位职责，包括临床研发阶段的QA，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，林博士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阶段中质量体系及产品质量。林博士曾参与全球领先的单抗产品上市工作，包括Avastin, Perjeta, Kavoltry。林博士在欧美亚同行中享有很好的声誉，活跃与世界级的专业会议讲台。2015年初，林博士归国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。之后又担任另一家国内知名生物制药企业的总经理一职。2017年5月，林博士创立苏州驾玉生物医药有限公司，专注生物制药行业的质量管理承包服务。 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 a leading biopharma in China, responsible for GMP compliance and Quality management. Later, GM position for another leading Chinese biopharma. Dr. Lin founded Suzhou Jiayu Biomedical in May 2017, dedicated to providing world-class quality management services to the China Biopharm industry.
12:00 PM Establishing an Effective Framework for End-to-End Quality Management of Biopharma Supply Chain
· Embedding “quality by design” in all products
· Engaging the organization end to end to ensure effective knowledge transfer and quality management
· Promoting a vibrant and productive ecosystem of quality management for multiple channels