Marla Stevens-Riley PhD U.S. FDA
Marla Stevens-Riley PhD U.S. FDA Supervisory Microbiologist, OPQ, CDER
Dr. Marla Stevens-Riley is a Supervisory Microbiologist in the Office of Pharmaceutical Manufacturing Assessment in the Office of Pharmaceutical Quality. She supervises quality microbiology and manufacturing assessors in the evaluation of quality microbiology, manufacturing process/facility information for Abbreviated New Drug Applications, New Drug Applications, and Investigational New Drug Applications. She has over 20 years of experience performing quality microbiology assessments of sterile and non-sterile new and generic drug products. She is currently serving as the CDER liaison to the United States Pharmacopeia General Chapters- Microbiology Expert Committee. Other notable activities include serving as a subject matter expert for the Center for Drug Evaluation and Research Cannabis Working Group and serving as co-lead on the Parenteral Drug Association Technical Report 86:"Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing." Previously, she was a Supervisory Microbiologist, Master Microbiology Reviewer, and Quality Assessment Lead in the Division of Microbiology Assessment. During her scientific career, she has authored/co-authored over 15 peer-reviewed scientific publications; most recently as a co-author on the publication "Investigation of Microorganisms in Cannabis After Heating in a Commercial Vaporizer" (2023). She earned a B.S. in biology and a Ph.D. in microbiology. She completed a post-doctoral fellowship in microbial pathogenesis.