In 2017, Donald N. Klein ’82, Ph.D., became the first senior review chemist to be awarded the Food and Drug Administration (FDA) Distinguished Career Service Award from the FDA commissioner. Klein wrote complex regulatory documents that evaluated the safety of pharmaceutical drugs — work was critical to protecting the health and safety of United States citizens.
Donald Klein
Klein says that Allegheny College laid the groundwork for his scientific career — not only as a researcher but a communicator.
“During my inorganic lab, [Allegheny Professor Emeritus of Chemistry] Dr. Richard Bivens was giving a lecture and discussed how to become a successful scientist,” says Klein, who majored in chemistry with a minor in writing. “In addition to understanding the science, Dr. Bivens said you had to be a good writer and be able to express yourself. That really hit home.”
After graduating from Allegheny College, Klein attended the University of Pittsburgh School of Dental Medicine but knew dentistry wasn’t for him. An Allegheny mentor, Professor Emeritus of Chemistry Edward Walsh, helped Klein explore a new path.
“Dr. Walsh made organic chemistry a lot of fun and was my first introduction to organic chemistry. He had a huge influence on me,” Klein says. “In 1983, I called up Dr. Walsh and drove up from Pittsburgh to Allegheny to get lunch with him downtown. That’s when he told me about his connection to Emory University.”
From there, Walsh supported Klein’s efforts to enroll at Emory University, where he would earn his doctorate in synthetic organic chemistry.
Klein eventually became a synthetic organic scale-up chemist, contributing to two global patent inventions for the drug Avodart. Later employed by the FDA, Klein served as a review chemist, senior review chemist, and chemistry, manufacturing, and controls lead for the Center for Drug Evaluation and Research. During Klein’s 22-year career with the FDA, he resolved drug shortages, evaluated new drug applications and pharmaceutical packaging, and mentored fellow FDA employees.
After his time at the FDA, Klein became a consultant for Parexel Consulting and subsequently his self-owned company, DLK Consulting Services Inc., alongside his wife.
Today, Klein works at Arvinas as a regulatory affairs director of chemistry, manufacturing, and controls.
To those students interested in a regulatory affairs career, Klein offered this advice “Acquire an advanced degree in your field of interest and earn a master’s in regulatory science. You must understand the respective field before you regulate and develop policies.”
