Stephen H.
Senior Vice President, Cmc Scientific Excellence & Learning @Sai Life Sciences Ltd
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WORK HISTORY
Senior Vice President, Cmc Scientific Excellence & Learning @Sai Life Sciences Ltd
Cambridge, GB
EDUCATION
University of Liverpool
PhD, Organic Chemistry
University of Cambridge
Post Doc, Organic Chemistry
University of Oxford
MA, Chemistry
University of Oxford
BA Hons, Chemistry
ABOUT STEPHEN H.
Fellow of the Royal Society of Chemistry FRSC CChemExperienced technical and people leader in the pharmaceutical industry who has successfully built high-performing teams and delivered multiple Active Pharmaceutical Ingredient (API) Projects.Demonstrated ability to lead Projects across the whole API lifecycle from accelerated early phase supply through to the development of complex Quality by Design (QbD) control strategies for commercial file and launch. A ‘single point accountable decision maker’ who adopts an inclusive, enterprise, leadership approach soliciting input from colleagues with diverse styles and backgrounds. Ability to critique Projects, identify development risks and formulate options for risk mitigation to increase the probability of Project success and value creation. Extensive experience in reviewing and approving the CMC (Chemistry, manufacturing and controls) sections of API regulatory submissions including response to agency questions.Significant experience working with Contract Development and Manufacturing (CDMO) organisations in India, China and Europe to deliver Projects. Supported teams execute technology transfer from lab to manufacturing pilot plant and commercial facilities.Expertise in assessing the potential risk of API and drug product contamination with genotoxic compounds and working with Project teams to develop appropriate control strategies.Experienced, GSK accredited ‘JobPlus\' coach who has successfully coached colleagues in diverse GSK business units and helped them realise their own potential. Leader who fosters an environment where individuals have opportunity to grow and develop their talent in addition to meeting business objectives.Recognised for being pragmatic and ensuring Project deliverables are achieved whilst meeting high standards of Safety, Quality and technical delivery.Specialities : Technical development of new APIs | Synthetic Organic Chemistry | Process Chemistry | Externalisation | Technical transfer | CMC regulatory submission | CMC project planning | Risk identification and mitigation | Genotox risk assessment (GRA)| People leadership | Coaching | Team building | People development | Performance management | Strategic workforce planning | Change management
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