Pat Patrick

James M. (Pat) Patrick has been consulting for over 20 years to technical, biological and pharmaceutical companies in the area of strategic operations (manufacturing) planning, product development and start-up operations. During the last 10 years Pat has focused his consulting services on start-up and early stage companies that are challenged with bringing complex biological, small molecules and chemical agents from discovery to production of GMP compliant clinical trial materials through Phase III.

His work with clients has included establishing design and build specifications for fully integrated manufacturing operations including research and kilogram production laboratories. Increasingly he works with early stage companies on outsourcing strategies that integrate contract technical and regulatory expertise into client product development teams. In addition, Pat consults on organizational development and staffing requirement for critical operations and technical hires. Pats clients have included Vertex Pharmaceutical, Millennium Pharmaceutical, Cubist, Progenics, GlycoGenesys, and Point Therapeutics.

Pat's industry experience includes positions at Serono Laboratories, Ajinomoto, USA and Cutter Laboratories (division of Bayer, AG), At Serono, Pat served as project manager for the design and construction of recombinant DNA laboratories. At Ajinomoto he was US Quality and Regulatory Operations Manager, responsible for the technical transfer of manufacturing and analytical technology from Japan to US large scale fermentation operations, focusing on quality operations, regulatory compliance and customer technical service. At Cutter Laboratories Pat was responsible for building quality control and quality assurance systems starting from construction of the manufacturing facility to full production and regulatory compliance.

Pat's career has included a wide range of speaking engagements at professional meetings including the Parenteral Drug Association (PDA), the FDA/PDA annual meetings and other industry seminars and workshops. He holds a BS in Zoology and an MS in Microbiology.