Biography

Raina Olexa, MS, RAC has worked in the medical research and pharmaceutical fields for 20 years, gaining experience in pre-clinical, clinical and commercial manufacturing aspects of the drug development lifecycle. At Drexel University College of Medicine, Ms. Olexa conducted research to assess recovery of function in animal models of spinal cord injury. From this pre-clinical position she moved into clinical and commercial drug manufacturing, working in vaccine operations at Merck and biologic drug operations at Bristol Myers Squibb. After gaining significant GMP experience, Ms. Olexa transitioned into clinical research supporting international Phase I-IV clinical trials. She has held senior level quality assurance positions at several global CROs ensuring that clinical trials are conducted ethically and in accordance with global regulations. Ms. Olexa holds a Master of Science degree in Bioscience Regulatory Affairs from Johns Hopkins University and Bachelor of Science degree in Biobehavioral Health, with a specialization in Neuroscience, from Pennsylvania State University. She is currently completing her doctoral dissertation in Regulatory Science at the University of Southern California.

Education

MS from Johns Hopkins University (2010)

Area of Expertise

Biologics Drug Product Formulation and Manufacturing, Clinical research, Drug development, FDA and USDA Regulatory, Global Regulatory Affairs, ISO 9001 Internal audits, pharmaceutical sciences, Quality Assurance, Quality improvement