Isaac Kennedy
Executive Director @Exelixis
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WORK HISTORY
Executive Director @Exelixis
Alameda, CA, US
Provide strategic planning, guidance and technical expertise regarding operational aspects of API development and commercial manufacturing at contract manufacturers; lead overall API development and manufacturing planning (pre-clinical - commercialization) to support filing activities through registration and validation batches; manufacturing co-ordination with Supply Chain group; management of CDMO activities, and overall CMC development and strategy.
EDUCATION
Memorial University, Newfoundland and Labrador
Medicinal and Pharmaceutical Chemistry
University of Ottawa
Doctor of Philosophy (PhD), Medicinal and Pharmaceutical Chemistry
McMaster University
Post doctoral felllowship, Bioorganic Chemistry
SKILLS
ABOUT ISAAC KENNEDY
An adaptable and forward-thinking hands-on development and medicinal chemist with vast expertise in project management, research and development, manufacturing, product development, quality control, technical operations management, contract management, financial management, and strategic planning in biotech and pharma. As an analytical performer, seizes opportunities to resolve issues and secure smooth operations. Leverages outstanding communication skills to coordinate with internal and external resources, ensuring the achievement of mutual objectives. An accomplished leader and producer who consistently delivers top results. Extensive experience in organic chemistry, medicinal chemistry, process optimization / development and industry experience, including independent and collaborative research; completed > 50 projects.Demonstrated leadership and strong ability to meet aggressive timeline; adapt and work in rapidly changing environment, and handling multiple projects. Projects completed on time.Demonstrated abilities to take initiative provide strategic leadership, problem solve, work in teams, develop people and communicate clearly in writing and verbally.Process validation and NDA experienced. Strong GMP experience; GMP rules and regulations and ICH guidelines. Strong track record of manufacturing small molecules in all stages of development including commercialization.Experience in CRO/CMO management. Extensive hands-on laboratory and analytical experience: NMR, HPLC, TGA, GC-MS, FTIR, UV-Vis, LC-MS; various types of chromatography and traces analysis.Specialty: CMC Developemnt, Technical Operations, Process and Organic Chemistry, GMP, Project Management, Outsourcing Management, Pilot Plant Manufacturing, Quality Assurance
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