Scott Steffen, CDRH

CDR Scott Steffen is a United States Public Health Service Officer serving as a Senior Program Management Officer for the United States Food and Drug Administration (FDA) in the Office of Readiness & Response. Over 4 years in this capacity he assisted in responses for COVID-19, highly pathogenic avian influenza, various healthcare associated infections, and numerous hurricanes. Currently, he has been also serving as the Ethylene Oxide Incident co-lead for four years. He has over 15 years of emergency response and regulatory experience spanning both the Center for Drug Evaluation and Research (CDER) or Center for Devices and Radiological Health (CDRH). Earlier in his FDA Career, he served as a microbiology/sterility reviewer and/or Team Lead for both CDER and CDRH completing over 800 sterility assurance reviews of Premarket Applications. He has Bachelor of Science degree from the Pennsylvania State University in Biochemistry and a doctoral degree in Biochemistry and Molecular Cell Biology from the Johns Hopkins Bloomberg School for Public Health. He also completed a post-doctoral fellowship studying enzymatic mechanisms of various Ebola proteins at Fort Detrick. Afterwards, he held various research positions investigating potential cancer targets and vaccine candidates at three different biotech companies before joining FDA. CDR Steffen holds five certifications as a Certified Quality Improvement Associate, Certified Quality Inspector, Certified Quality Technician, Certified Quality Process Analysis, and Certified Six Sigma Yellow Belt from the American Society of Quality.