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Pharmaceutical Sciences and Good Manufacturing Expert Consultant Resume

Resume of JHE, Ph.D. Consultant
Principal Industries Served:
  • Pharmaceutical
  • Current Good Manufacturing Practices
  • Pharmaceutical Product Development
  • Legal
  • Drug Product Patent Infringement

Education:

This expert received a Ph.D. in Physical Pharmacy and a M.S. in Hospital Pharmacy at the University of Michigan.

This expert received a B.S. in Pharmacy from Rutgers University.


Expertise and Services:

Pharmaceutical Sciences and Good Manufacturing Expert Consultant Resume

This expert specializes in pharmaceutics and biopharmaceutics, biostatistics, industrial pharmacy and experimental design. Further expertise includes physical pharmacy, dispersed systems, solution chemistry, ionic equilibria and current good manufacturing practices.

This consultant has extensive experience in research and development and pharmaceutical development, and has provided successful expert testimony in court / deposition appearances on drug product patent infringement / validity.


Professional Experience:

Consultant, Kevin Kennedy Associates Inc.

Providing expertise in Pharmaceutical Sciences, current Good Manufacturing Practices, pharmaceutics, biopharmaceutics, expert testimony, and related expertise to a wide variety of clients.

 

Lecturer, Graduate Studies, major university School of Pharmacy

Lectured on topics including: Current Good Manufacturing Practices (CGMP's) Validation (analytical, bioanalytical, equipment, product, etc.) Pharmaceutical Stability Testing Pharmaceutical Experimental Design Introduction to the Pharmaceutical Industry IND, NDA, aNDA, and over-the counter drug development

 

FDA consultant and expert witness for Good Manufacturing Practices

Professor of Pharmaceutical Sciences, and Supervisor of Graduate Education for the Department of Pharmaceutical Sciences, Medical University of South Carolina

Professor of Pharmaceutical Sciences, and Director, The Pharmaceutical Development Center, Medical University of South Carolina

Undergraduate and graduate teaching and research in the areas of Industrial Pharmacy and Pharmaceutics, Medical University of South Carolina The Pharmaceutical Development Center contains approximately 15,000 square feet of Pharmaceutical R&D/Production space that meets the Current Good Manufacturing Practices. It is utilized for contract R&D and production, employing > 17 people.

 

Director, Corporate Product Development, Marion Laboratories, Inc., Kansas City, MO

Administrative and technical responsibility for new product formulation, production and shipping of clinical supplies, pilot laboratory, expiration dating, resolving production problems involving formula or processing, resolving QC/Production disputes regarding specific batches, or recalls. During this time the department developed the formulations for products that represented about 90% of the company sales. Budgetary responsibility for 28 people and a budget of over $ 3,000,000.

 

Professor of Pharmacy (tenured), Philadelphia College of Pharmacy and Science

Also served in positions of Associate Professor of Pharmacy, and Assistant Professor of Pharmacy. Was coordinator of graduate studies for the School of Pharmacy. Undergraduate teaching in the areas of pharmaceutics, biostatistics, and biopharmaceutics. Graduate teaching in the areas of ionic equilibria, solution kinetics, physical pharmacy, dispersed systems, computer programming and analysis of data. Graduate advisor for 26 students at the M.S. and Ph.D. levels.

Additional Experience:

Recipient of grants related to Correlation of Metal Binding and Drug Activity, and Metal Binding and Drug Allerginicity.

Pharmaceutical Development Center. One hundred and fifty two contracts from over 80 companies

18 successful court / deposition appearances on drug product patent infringement/validity


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