Biography
I earned a Pharmacy degree from Oregon State University and Ph.D. in Pharmaceutical Sciences from the University of Kentucky, specializing in sterile product and process development.
Utilizing my education, accumulated experience and expertise I have developed small molecule and biotechnology products in organizations including US Public Health Service - NIH Clinical Center, The Upjohn Company, Genentech, Glaxo (Glaxo-Wellcome), Biogen, and Pfizer. Responsibilities have included product development, product and process trouble shooting, leading development teams (formulation, analysis and packaging development), the development and advancement of sterile product technologies including process and unit operation models, and evaluation of new delivery technologies. I have contributed to and reviewed regulatory submissions.
Products developed include Activase® (Tissue Plasminogen Activator (TPA)), Zofran® (Ondansetron), Imitrex® (Sumitriptan), and Ultiva® (Remifentanil). I led the Combivir® development team, an oral solid dosage form, successfully developing the product and submitting regulatory documents in record time, for which the team received a Glaxo Corporate Award. I have successfuly solved manufacturing issues including increasing the manufacturing throughput of Avonex® ten fold, scaling-up Activase® in record time with minimal resources and reducing freeze-drying cycle times by as much as fifty percent. Successful in a team environment I have initiated and led local and international teams, established corporate networks responsible for product development, technology sharing (freeze drying), process modeling, technology transfer, and career development.
My consulting has included various companies including Norvartis (vaccine development), Alnylam (formulation), and Patheon. I have authored numerous papers, book chapters, and given presentations in the areas of Sterile Product Development, Sterile Process Development, Filtration, Lyophilization, and personnel development. I am a successful career coach and mentor.