A experienced scientist and leader in analysis, chemistry and regulatory affairs in CMC drug development with 36 years of experience in increasingly senior positions.
Mike is a consultant in analysis and chemistry with 36 years of experience in the pharmaceutical industry with GSK. He has a track record of delivering robust processes and analytical methods to manufacturing and successful marketing submissions. His also a trained specialist in leadership and people development.
Mike holds a PhD in Chemistry from Imperial College working on Chiral Molecular Recognition. He also holds an MSc in Molecular Spectroscopy and a BSc in Chemistry. Mike began his career in GSK as an NMR expert before going on to lead separation sciences teams. He has has been an Analytical Director of departments in Harlow, Dartford and Stevenage. Mike initiated GSK’s chemistry support for oligonucleotides before going on to lead UK development chemistry for GSK as Vice President of API Chemistry & Analysis UK. Before leaving GSK, Mike took on a special project to use R&D expertise to improve the robustness of API processes in manufacturing. Mike has been a champion of new technology in chemistry and analysis including automation and biosynthesis. He also has extensive experience of due diligence and technology transfer. Mike has also run a number of cross functional teams with in due diligence and technology transfer.
Mike has published a number of papers, presented at a number of international meetings and co-edited 3 books on Analytical Chemistry. He has acted as a personal coach and mentor to colleagues and has run leadership training courses for senior leaders in GSK.
He now works as a consultant specialising in analysis, chemical development, manufacturing and CMC regulatory affairs