Jim Spavins is recently retired from Pfizer, where he was Senior Vice President of Pfizer’s PTx Pharmaceutical Sciences organization. During his 36-year career at Pfizer, Spavins held numerous positions, starting as a process and fermentation engineer in manufacturing, then moving to chemical process development and head of the analytical research and development department. He has been the pharmaceutical sciences team leader of several late stage development candidates during his career. He was a member of ISPE’s Regulatory Affairs Committee and has presented at numerous forums on quality by design, including application to early and late stage candidate development and use of process analytical technology. His wide interest in effective product development includes being a recipient of a Presidential Citation for Green Chemistry in 2002. Spavins did his undergraduate work in chemistry at Queens College City University of New York and has Masters degrees in chemical engineering and analytical chemistry, both from State University of New York at Buffalo.