Head of CMC at Prosidion Supported pre-clinical/clinical development of seven drug candidates for diabetes and obesity by providing integrated CMC management of over 40 projects to more than 35 contractors in Europe, US, Japan, India and China. Managed over 30 manufacturing campaigns producing materials (intermediates, active pharmaceutical ingredients and drug products) from kg to ton scale. Set up and managed a formulation laboratory to support formulation development and… Show more Head of CMC at Prosidion Supported pre-clinical/clinical development of seven drug candidates for diabetes and obesity by providing integrated CMC management of over 40 projects to more than 35 contractors in Europe, US, Japan, India and China. Managed over 30 manufacturing campaigns producing materials (intermediates, active pharmaceutical ingredients and drug products) from kg to ton scale. Set up and managed a formulation laboratory to support formulation development and outsourcing activities Contributed to over fifteen IND / IMPD submissions Negotiated and prepared numerous Development, Technical and Supply Agreements Developed strategies for meeting cost of goods targets; carried out risk assessments and created coherent risk mitigation strategies with respect to short and long term clinical supplies Developed an efficient strategy for frontloading of the CMC activities in order to expedite drug development Carried out CMC evaluation of in-licensing opportunities, participated in numerous due diligence efforts on behalf of Prosidion as well as for third parties Assessed and solved a large number of complex technical and organisational issues, leveraging support of third parties, fellow colleagues and a wide range of professional contacts Effectively and proactively negotiated win-win outcomes in multi-cultural environments, organisations and circumstances, delivering clear business benefits in terms of service levels, value enhancement, risk reduction and cost effectiveness Built an extensive world-wide network and knowledge of the global chemical and drug product manufacture, contract research providers, and outsourcing. Provided effective leadership to the CMC function, managed, supported and developed direct reports; managed external consultants Participated in numerous outsourcing conferences as a speaker; recognised by peers as an outsourcing expert Responsible for the CMC budgets Show less

As part of the global CMC team managed the process development and optimisation, critical process parameter studies, scale up, and process validation of erlotinib (Tarceva® API) at contractors including on-site supervision of manufacturing campaigns Co-ordinated the manufacture of starting materials and drug substance for commercial launch; planned and co-ordinated 26 manufacturing campaigns (kg to ton scale) Contributed to the preparations of the PAI inspections and to the CMC… Show more As part of the global CMC team managed the process development and optimisation, critical process parameter studies, scale up, and process validation of erlotinib (Tarceva® API) at contractors including on-site supervision of manufacturing campaigns Co-ordinated the manufacture of starting materials and drug substance for commercial launch; planned and co-ordinated 26 manufacturing campaigns (kg to ton scale) Contributed to the preparations of the PAI inspections and to the CMC sections of the NDA submission for Tarceva® Show less

Responsible for over 30 projects including high throughput synthesis, process research, custom preparation and multi-step plant projects to cGMP Co-inventor of a patented asymmetric hydrogenation process that has been successfully applied for the industrial scale manufacture of a drug Recognised internally and by clients for excellent project management and communication skills