Marla Stevens-Riley PhD U.S. FDA
Marla Stevens-Riley PhD U.S. FDA Supervisory Microbiologist, OPQ, CDER
Dr. Stevens-Riley is a Supervisory Microbiologist in CDER's Office of Pharmaceutical Manufacturing Assessment in the Office of Pharmaceutical Quality. She supervises assessors who evaluate the quality microbiology, manufacturing, and facility information of sterile and non-sterile drugs in Abbreviated New Drug Applications, New Drug Applications, and Investigational Drug Applications. Previously, she was a Master Microbiology Reviewer and Quality Assessment Lead in the Division of Microbiology Assessment, a policy lead in the Office of Policy for Pharmaceutical Quality, and a Team Leader in the Division of Microbiology in the Office of Generic Drugs. In addition, she is currently a liaison to the United States Pharmacopeia Microbiology Expert Committee and a member of the CDER Cannabis Working Group. During her scientific career, she has co-authored over 15 peer-reviewed scientific publications; been an invited speaker for internal and external presentations and trainings; and participated on several FDA guidance and Parenteral Drug Association Technical Report working groups. She earned a B.S. in Biology from the College of William and Mary and a Ph.D. in Microbiology from the University of Georgia. She completed her post-doctoral training in the Department of Microbiology and Immunology at the University of Texas Southwestern Medical Center in Dallas.