Profiles of Communities of Practice (CoP) leaders. These leaders are central to the success of ISPE’s CoPs, which spearhead the generation of ISPE’s gold standard content, including Good Practice Guides, Pharmaceutical Engineering articles, conference presentations, and training programs.
Anil Mathai first heard about ISPE 30 years ago. “I attended Drexel University, where you are required to complete three cooperative education jobs. One of mine was for Rhône-Poulenc Rorer, Inc. in Collegeville, Pennsylvania. While I was there, I learned about validation and decided that I wanted to be in pharmaceuticals as a chemical engineer.”
After completing her doctoral degree at Oklahoma State University, Sarah Pope Miksinski received a fellowship at the National Institutes of Health. While working there, she realized that research was not the best career path for her.
Rod Freeman started his career in the pharma-ceutical industry as an analytical chemist.
Growing up on a farm, Allen Koester thought he would design farm equipment after earning his degree in mechanical engineering.
Although he didn’t know it at the time, Nathan Temple’s service as a naval officer on the USS Asheville in Hawaii prepared him perfectly for a career in pharmaceutical engineering. “You learn so much, so quickly, on a submarine.”
The impact people have on others’ lives is not always obvious. For many, the Advil mini pill might not seem like a big deal, but for people who have trouble swallowing pills, like cancer patients, the tiny pill has made a huge difference in their ability to manage pain. It’s projects like that, as well as treatments for bladder cancer and transthyretin amyloidosis, that Tammy Spain is most...
Lorrie Vuolo-Schuessler has been involved with ISPE and GAMP® projects since 2002. She has authored or co-led 11 ISPE GAMP-focused guidance documents, including ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) and the ISPE GAMP® Good Practice Guide: Enabling Innovation - Critical Thinking, Agile, IT Service Management. She is Immediate Past Chair of...
An ISPE member since 1999, Charlie Wakeham has been active within the ISPE GAMP® community since 2001. A founding member of the GAMP UK Community of Practice (CoP), she is currently Chair of the GAMP Global CoP Steering Committee, one of the leaders of the GAMP Computer Software Assurance Special Interest Group (SIG), and a member of the ISPE Guidance Documents Committee. She has co-led or...
Michelangelo Canzoneri, PhD, is a seasoned leader in the digital transformation space within the healthcare and life science industry currently serving as the Global Head of Group Smart Manufacturing at Merck KGaA, Darmstadt, Germany. In this pivotal role, he functions as the primary business interface across the life science, healthcare, and electronics sectors, steering the incubation,...
Erich H. Bozenhardt is the Associate Director of Process Engineering in Regenerative Medicine Operations at United Therapeutics. Erich is an experienced bioprocess subject matter expert and internationally recognized authority in the areas of cell and gene therapy and bioprocessing. He has published more than 30 technical papers and is a frequent presenter at conferences.
