Runkai Li
About Runkai Li
Runkai Li is the Director of Analytical R&D and QC at Mirati Therapeutics, where he leads analytical development for late-stage drug projects. He has a strong background in analytical chemistry, with previous roles at Bristol Myers Squibb, Celgene, and Allergan, and holds advanced degrees from Peking University and Queen's University.
Work at Mirati Therapeutics
Runkai Li serves as the Director of Analytical R&D and Quality Control at Mirati Therapeutics, a position he has held since 2021. In this role, he leads the analytical development of late-stage drug candidates, focusing on providing phase-appropriate strategies to ensure successful progression through the development pipeline. He is also responsible for managing the analytical development budget, ensuring that resources are allocated efficiently to meet project goals.
Previous Experience at Bristol Myers Squibb
Prior to his current role, Runkai Li worked at Bristol Myers Squibb as a Senior Principal Scientist, serving as the Analytical Technical Lead from 2017 to 2021. During his four years in Summit, New Jersey, he contributed to various analytical projects, leveraging his expertise in method development and validation within the pharmaceutical sector.
Background in Analytical Chemistry Education
Runkai Li has a strong educational foundation in analytical chemistry. He earned his Master of Science degree from Peking University, where he focused on Analytical Chemistry. He further advanced his studies at Queen's University, obtaining a PhD in the same field. His academic background supports his extensive experience in the pharmaceutical industry.
Expertise in Pharmaceutical Development
Runkai Li specializes in method development, validation, and technology transfer within the pharmaceutical industry. He has extensive experience managing global Contract Research Organizations (CRO) and Contract Manufacturing Organizations (CMO) activities. His expertise extends to global regulatory submissions, including Investigational Medicinal Product Dossier (IMPD), Investigational New Drug (IND), New Drug Application (NDA), Clinical Trial Application (CTA), and Marketing Authorization Application (MAA).
Career Progression and Roles
Throughout his career, Runkai Li has held various significant positions in the pharmaceutical industry. He worked as a Principal Scientist at Celgene from 2017 to 2019, where he continued to develop his analytical skills. Prior to that, he served as a Senior Scientist at Allergan from 2010 to 2017 and as a Scientist at Labstat International ULC from 2007 to 2010. His diverse roles have contributed to his comprehensive understanding of analytical development processes.