Management Team

Karen M. Vitale
Principal Consultant

Ms. Vitale, Principal Consultant and Co-founder of Pharma Technology Resources, focuses on project management activities for pharmaceutical product development and production launch, manufacturing regulatory compliance, and Quality Assurance systems. She is a pharmaceutical industry veteran with a diverse background in manufacturing operations management, FDA regulatory compliance, process and pharmaceutical dosage development, and engineering projects. She has held Production Manager, Manufacturing Engineer and Research Scientist positions at Syntex, a major pharmaceutical company.

Karen Vitale, Full Biography

Tim Chalmers
Principal Consultant

Mr. Chalmers, Principal Consultant and Co-founder of Pharma Technology Resources, is a pharmaceutical industry professional with a strong background in manufacturing engineering services and manufacturing regulatory compliance. In his consulting practice, he has been a key provider of turnkey pharmaceutical engineering services, providing leadership on design, installation, validation and training for complex manufacturing systems. His focus in manufacturing regulatory compliance has been on the preparation and assessment of operating procedures and documentation, and preparation for production launch. He has held engineering positions in equipment design with Shaklee Corporation, a large cosmetic and food supplements company, and in manufacturing engineering with Syntex Laboratories, a major pharmaceutical company.

Tim Chalmers, Full Biography