John is a Senior Consultant with over 25 years of experience in solving Chemistry, Manufacturing and Controls (CMC) development problems and bringing projects to approval and launch with Glaxo, Glaxo Wellcome, and GlaxoSmithkline. He has a broad range of CMC development experience which encompasses complex dosage form development spanning a large portfolio of projects developed both internally and with a wide range of external partners.
He authors and reviews CMC sections of submissions, creating solutions to development issues that puts them in the proper context to achieve approval. He has a strong quality focus with extensive experience in preparing international and domestic sites and projects for successful regulatory inspections. John has hands on experience with investigating data integrity and quality issues with CMO partners in the emerging markets.
John has had overall CMC responsibility for four NDA/MAA and one sNDA approvals. During his tenure, he has developed and implemented the organizational design for two departments, leading up to 30 Ph.D. and B.S. formulation and analytical scientists. He has developed and implemented numerous business process such as the CMC governance process for overseeing projects executed with partners in the Emerging Markets and the laboratory data review process used by GSK Pharmaceutical Development staff world-wide. In his most recent position, he had responsibility for all CMC activities in Emerging Markets R&D where he managed a development portfolio of over 20 projects with development partners in India, Korea, and Singapore.
John earned his Ph.D. in Organic Chemistry from the University of Illinois at Urbana-Champaign after receiving a B.A. in Chemistry from Indiana University