After earning his degree in biochemistry from Fudan University in Shanghai, RJ moved to the US to work on advanced degrees at the University of Maryland and Purdue University.
“After I obtained my Ph.D. in analytical chemistry from Purdue, I joined Amgen’s Process Development department as an analytical chemist supporting multiple blockbuster products. I was fortunate to be groomed by many biotech industry pioneers. I was also able to provide quite a few creative and effective solutions to challenging problems to avoid stockouts.”
From Amgen, RJ went to Eli Lilly and Company and then AstraZeneca, where one of the challenges he faced involved developing a QC network across labs at 30 manufacturing sites. “Our executive vice president at the time visited all the sites and said that while they looked great, it was like visiting 30 different companies; there was no standardization at all. AZ’s Head of Quality came up with the 4S strategy—Standardize, Simplify, Share, Sustain—and I successfully started a network to apply this strategy that led to the adoption of advanced electronic systems, new technologies, and efficiency gains across the company. The pharmaceutical industry is highly regulated, and it would be great if we could have this type of harmonization across companies.”
The ISPE QC/Analytical CoP was established in 2022 to provide a forum for knowledge sharing on a range of topics including out of specification (OOS) investigations, method validation, compendial harmonization, analytical methods lifecycle management, and implementing innovations, such as real-time release.
“One of the first projects the QC CoP is working on is to define best practices for the handling of OOS results. We have assembled a group of subject matter experts across representative companies, and then we also have people from institutes, who bring a fresh perspective. There is so much knowledge that the group possesses. And a lot of CoP members share the same goal as me—to make medication accessible and affordable.”
