Jon Harris
About Jon Harris
Jon Harris serves as the Senior Director of Regulatory Affairs CMC at Bolt Biotherapeutics, where he has worked since 2021. He has extensive experience in regulatory affairs, having held various positions at notable companies including Genentech and AstraZeneca, and has a strong reputation for collaborating with FDA leaders.
Work at Bolt Biotherapeutics
Jon Harris serves as the Senior Director of Regulatory Affairs CMC at Bolt Biotherapeutics, Inc. He has held this position since 2021, contributing to the company's regulatory strategies in Redwood City, California. His role involves overseeing the regulatory aspects of chemistry, manufacturing, and controls, ensuring compliance with industry standards and facilitating the development of biotherapeutic products.
Education and Expertise
Jon Harris studied at the University of California, Berkeley, where he achieved a specialization in Drug Development and Regulatory Science from 2010 to 2012. He also holds a Bachelor of Arts degree in History from the same university, completed from 1982 to 1986. His educational background supports his extensive expertise in regulatory affairs within the biopharmaceutical industry.
Background in Regulatory Affairs
Jon Harris has a comprehensive background in regulatory affairs, with over two decades of experience in the field. Prior to his current role, he worked at Genentech for 14 years in various regulatory positions, including Regulatory Advisor and Regulatory Affairs Senior Manager. He also held senior roles at Omeros Corporation and AstraZeneca, focusing on regulatory strategies and compliance.
Achievements in Regulatory Science
Jon Harris has established a long-standing reputation with FDA leaders, facilitating partnerships and organizing public forums on antibody drug conjugates (ADCs). He co-chaired these forums, engaging with FDA reviewers to discuss regulatory challenges and advancements in the field. Additionally, he designed the Regulatory Affairs Certificate Program at the University of California, Santa Cruz, contributing to the education of future regulatory professionals.