George Cox

About George Cox

Distinguished professional offering over 30 years of leadership in the biotechnology, pharmaceutical and medical device industries. Successfully managed cross-functional teams to create visions for organizations; developed the strategy to achieve the vision and provided the leadership to assure its execution. Effective at promoting continuous improvement programs to meet dynamic corporate, industry and regulatory requirements. Demonstrated expertise meeting the requirements for moving products from development to commercial approval including multiple agency inspections, both domestic and international. Fostered exceptional customer relationships by developing a culture empowered to deliver a premier level of service. Successfully outsourced manufacturing and packaging operations to enhance flexibility and meet demand fluctuations. Collaborates with a high performance team to drive the successful management of strategic corporate projects.

Experience

1. Vice President, Technical Operations

   Windtree Therapeutics, Inc

   Apr 2008 — Present

   Vice President, Technical Operations• Formerly Discovery Labs the name change in April, 2016 began rebranding process. Our commercial product, Surfaxin, was removed from the market in April 2015 and our manufacturing facility was closed in June 2015.• Responsible for manufacturing, supply chain and analytical testing of our lyophilized lucinactant and our medical device to support our clinical trials. Additionally responsible for the Project Management function. Managed the development of our lyophilized lucinactant from R&D to full scale manufacturing at our Contract Manufacturing Organization’s facility. Developed a Risk Analysis to minimize the impact of a transferring our process from one facility to another at the drug CMO. Direct the Device Contract Manufacturing Organization for Phase 2 clinical supply and the development of the Next Generation device to support our Phase 3 and commercial applications. Contracted for the development and validation of test methods for the lyo product using the Surfaxin methods as the basis to move forward. FDA requested Emitted Dose testing also to be validated. Manage our Clinical Supply Organization to support our Phase 2 trial in the United States, Canada, Europe and Latin America. Responsible for budget and supply agreement negotiation for all CMO’s, CSO and API suppliers.• Direct the Project Management function consisting of multiple permanent and situational cross-functional teams associated with the current clinical trial and the planning of future trials.• Developed Clinical Trial metrics to track enrollment and the performance of our • As a member of the senior management team participated in the development of the criteria and ultimate selection of the CRO for this very complicated Phase 2 trial

Education

• Villanova University

  Bachelor, Science Accountinig

  1978

Skills

• Biotechnology