May / June 2023

CoP Leader Profiles: Roujian “RJ” Zhang

Marcy Sanford
CoP Leader Profiles: Roujian “RJ” Zhang

Roujian “RJ” Zhang is Chair of ISPE’s new Quality Control (QC)/Analytical Community of Practice (CoP) Steering Committee. He is also Chief Quality Officer at Evive Biotech, responsible for all aspects of quality for the company, ensuring safety and efficacy, making critical quality decisions, and keeping the company up to date with new regulations. RJ became interested in the pharmaceutical industry early in his life. “My grandfather died of pneumonia in the 1950s. Because he lived in China, he did not have access to penicillin, even though it was invented and being used to treat infections. My cousin, who now works for the FDA, has been studying malaria treatments for decades. Growing up I heard stories about both, and my goal became to not only join the pharmaceutical industry, but to work to make innovative medicine accessible to everyone, and to lower the cost of the medicine as much as we can from the manufacturing perspective.”

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.”