Biologics Consulting Group, Inc. Larry K. Winberry, Ph.D., joined Biologics Consulting Group, Inc. (BCG) as a Senior Consultant for Process Development and Manufacturing in September 2001. Dr. Winberry is a Biochemist (Ph.D., University of California, Riverside) who brings to the firm over fifteen years of broad-based experience in the biopharmaceutical industry, principally in the areas of process development, process validation, Quality, and manufacturing. Most recently, as Vice President, Manufacturing Operations for BioPort Corporation, he was responsible for directing all aspects of the manufacture of Anthrax Vaccine AdsorbedTM. In addition, Dr. Winberry authored the Chemistry, Manufacturing and Control section for the company's recently approved regulatory submission for this vaccine and served as the Project Manager for the Process Validation Team assigned to this project. Prior to his most recent experience, Dr. Winberry was the Director of Quality Assurance and Quality Control at Baxter's Hyland-Immuno plasma fractionation facility in Rochester, MI. In that capacity he was responsible for all on-site matters relating to Quality Systems and Compliance including Product Release, QA, QC, Validation, Plasma Supplier Quality, Stability, Training, and Change Control. Dr. Winberry has also held positions of increasing responsibility in several areas of vaccine process scale-up, development and Quality Systems at what was previously Lederle-Praxis Biologics. There he was responsible for troubleshooting and improving existing vaccine manufacturing processes, as well as developing, validating and transferring new processes to manufacturing. He was instrumental in the development and transfer of the manufacturing processes for two of the company's vaccine products and was a key contributor to the company's successful efforts to license those products. Dr. Winberrys' scientific and technical expertise in process development, validation and manufacturing operations, along with his extensive Quality Systems and FDA Team Biologics inspection experience will significantly contribute to the expertise at BCG. View Dr. Winberry's Curriculum Vitae
Page Updated April 13, 2010 |
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