Lijun Duan, Ph.D.
About Lijun Duan, Ph.D.
Lijun Duan, Ph.D., serves as the Associate Director of CMC Analytical in Tech Operations at Mirati Therapeutics, where he leads analytical activities for oncology drug development. With a background that includes senior roles at PPD, BioDuro, and Gossamer Bio, he has extensive experience in method development and optimization in the pharmaceutical industry.
Work at Mirati Therapeutics
Lijun Duan, Ph.D., serves as the Associate Director of CMC Analytical in Tech Operations at Mirati Therapeutics since 2021. In this role, Duan leads analytical activities specifically focused on oncology drug development programs. He interfaces with multi-functional project teams to design and execute phase-appropriate analytical strategies. His responsibilities include managing analytical activities related to method development, optimization, troubleshooting, qualification, and validation for starting materials, process intermediates, drug substances, and drug products, both internally and across Contract Manufacturing Organizations (CMOs). Duan also generates guidelines and Standard Operating Procedures (SOPs) to standardize tasks within Analytical Development.
Previous Experience at PPD
Prior to joining Mirati Therapeutics, Lijun Duan worked at PPD as a Senior Group Leader from 2005 to 2016 in the Madison, Wisconsin Area. During his eleven years at PPD, he contributed to various analytical projects and gained extensive experience in the field of analytical development. His tenure at PPD provided a strong foundation for his subsequent roles in analytical science and operations.
Experience at BioDuro and Gossamer Bio
Lijun Duan held the position of Associate Director at BioDuro from 2016 to 2019 in the Greater San Diego Area. Following this role, he worked at Gossamer Bio as Associate Director of CMC Analytical Science from 2019 to 2021 in San Diego, CA. In both positions, he was involved in analytical science and contributed to the development of drug products, further enhancing his expertise in the pharmaceutical industry.
Education and Expertise
Lijun Duan earned his Bachelor of Science in Chemical Engineering from Harbin Engineering University from 1993 to 1997. He then pursued a Master of Science in Food Science at Jiangnan University from 1997 to 2000. Duan continued his education at the University of Arkansas at Fayetteville, where he obtained his Ph.D. in Chemical Engineering from 2001 to 2005. His educational background provides a solid foundation for his expertise in analytical development and drug formulation.
Technical Contributions and Responsibilities
At Mirati Therapeutics, Lijun Duan is responsible for providing guidance in resolving complex technical issues and reviewing deviation events and failure investigations at contractor sites. He offers technical input for Out of Specification (OOS) and Out of Trend (OOT) investigations in coordination with internal and external quality control, quality assurance, and regulatory groups. Additionally, he collaborates with IT to implement analytical software solutions to enhance analytical development processes.