James Frederick Pruden
Practice Head, Manufacturing Operations
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During Mr. Pruden's 35-year career in the pharmaceutical industry, he has directed all facets of manufacturing, QA compliance, business development, QC, engineering, supply chain management, and other manufacturing functional departments. Mr. Pruden has a proven ability to assess operations and provide systems and procedures to maximize effectiveness and productivity. Prior to joining PharmaDirections, Mr. Pruden was serving as a consultant providing regulatory compliance, manufacturing, validation, engineering, supply chain management, business analysis, and business development consulting services to pharmaceutical manufacturing companies. Mr. Pruden also served as Vice President of Manufacturing Operations at AAI Pharma. At AAI Pharma, Mr Pruden had P&L responsibility for sterile and solid dosage manufacturing operations, management of customer projects for drug development, contract manufacturing for commercial and clinical supplies. He was also responsible for technical transfer of acquired products from OEM manufacturers and R&D projects to either in-house facilities or suitable outside facilities. Previously, Mr. Pruden was VP of Manufacturing Operations at King Pharmaceuticals, General Manager at Novo Nordisk, Executive VP at Lyphomed. During this time, Mr. Pruden was heavily involved in all aspects of sterile fill, solid dosage, semi solid ointments and creams and liquid fill manufacturing operations as well as involvement with CMC sections for ANDA and NDAs. Mr. Pruden began his career at Abbott Laboratories as a Production Manager. He earned a B.S. in Mathematics from the University of North Carolina at Chapel Hill.
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