The Leader in Quality Life Science Training

Specialties: Pharmaceutical, GLP, Regulatory

Biography

Julie Barnhill, Ph.D. is a Senior Consultant with Pace Labs (formerly Meridian BioGroup LLC) and provides QA Compliance expertise to Biopharma/Pharmaceutical companies with products in preclinical, clinical, and commercial stages of drug development with the primary objective of helping clients advance their drugs through pipelines and regulatory processes. Her clients include a number of virtual drug companies whose GMP and GLP operations are completely outsourced along with small and medium clinical phase organizations and large commercial drug companies. She has assisted start up organizations to develop and implement GMP compliant systems and has supported many companies prepare for FDA inspections. Further, she has helped companies transition from preclinical to first-in-human phase 1 compliance along with phase 2 to phase 3, and clinical phase 3 to commercial launch.


Prior to Pace, Dr. Barnhill was the QA head for Osiris Therapeutics, head of QA Compliance at Alpharma (now Actavis) and Director of Quality Control and Analytical Development at Chesapeake Biological Laboratories (now Emergent). Her career has been focused on the quality and compliance of mostly parenterals and she has experience with inhalation and nasal solutions along with orally administered medications. 


A deep understanding of drug compliance aligned with her client’s needs underscores Dr. Barnhill’s effective approach in her successful collaborations with a wide variety of clients. Dr. Barnhill is a Board member of the PDA Capital Area Chapter and was a member of the Adjunct Graduate Faculty at the Johns Hopkins University Advanced Academic Programs in Biotechnology and Bioscience Regulatory Affairs and is a Lecturer at Mount St. Mary’s University, M.S. Program Biotechnology and Management.


Dr. Barnhill holds a PhD in Bioinorganic Chemistry from the University of Pennsylvania in Philadelphia, Pennsylvania and a B.S. in Chemistry from Trinity College in Hartford, CT.


Share by: