Provision of independent advice relating to the strategic management of CMC aspects of small molecule pharmaceutical development programmes, embracing drug substance (API) and drug product, including the selection and management of outsourced R & D and manufacturing contracts for virtual pharma. Also provision of independent expert-witness testimony in pharma patent litigation.

- Key responsibility: The development, third party manufacture and supply of Novexel’s Investigational Medicinal Products, embracingo Chemical process research and developmento Active Pharmaceutical Ingredient (API) manufacture and cost reductiono Formulation identification and developmento Drug product manufacture and clinical supply logisticso Analytical, regulatory and quality aspects associated with the aboveo Development and implementation of short and long term manufacturing and supply chain strategies

- Member of the Executive Team responsible for managing the progression of a portfolio of anti-infective assets (including NXL103 and NXL104) from preclinical through to Phase II clinical trials (and positioning for Phase III readiness), leading ultimately to the successful sale of the company to AstraZeneca for ~$500M- Key responsibility: The development, third party manufacture and supply of Novexel’s Investigational Medicinal Products, embracingo Chemical process research and developmento Active Pharmaceutical Ingredient (API) manufacture and cost reductiono Formulation identification and developmento Drug product manufacture and clinical supply logisticso Analytical, regulatory and quality aspects associated with the aboveo Development and implementation of short and long term manufacturing and supply chain strategies

- Consultancy and CMC management for a range of pharmaceutical and biotech companies, as well as Universities, providing detailed technical advice and strategic guidance, with customers across Europe, USA, Canada, Australia, Singapore- Pharmaceutical Operations Development Advisory Board Member, Vertex Pharmaceuticals- CMC due diligence exercises on novel pharmaceutical chemical entities prior to licensing deals and investments- Expert witness testimony in UK Royal Courts of Justice regarding patent validity challenges relating to perindopril, and in other territories regarding patent validity challenges for the world’s largest selling pharmaceutical product, Lipitor (atorvastatin). - Led technical scoping project for new UK Bioprocessing Centre at Centre for Process Innovation (CPI)- Performed technical and market surveys for University spinout companies (e.g. PhosphonicS)- Managed CMC aspects of development projects for biotech companies, through third party contractors- Taught Chemical Development and Scale-Up course to professional industrial chemists- Researched, developed and personally delivered two completely new training courses (on Green Chemistry and Organic Synthesis) for professional chemists

- Directed 170 Chemical R & D staff at 3 European sites (Sandwich & Sittingbourne UK, Freiburg Germany), with two Pilot Plants, a kilolab and a number of chemistry laboratories. - Ensured efficient and effective delivery of the Pfizer European Human Health and Animal Health project portfolios, some 25 projects spanning the complete spectrum from Discovery through Exploratory Development, Full Development and Product Enhancement. Responsible for the design, development and delivery of commercially viable synthetic routes to drug development candidates, supplying drug substance to meet the demands of toxicology, clinical and formulation development programmes, and generating knowledge to underpin regulatory filings and transfer to commercial manufacturing.- Led Pfizer’s Worldwide Pharmaceutical Sciences Veterinary Medicine Portfolio, with a budget of ~$23M and multi-disciplinary (drug product and drug substance) projects sited in Groton (CT, USA), Kalamazoo (MI, USA) and Sandwich (UK). Also accountable for post-Pharmacia integration Animal Health business continuity in Worldwide Pharm Sci.- By personal initiative, led and championed major development cost reduction initiative (ultimately coined “The Spargo-5”) for Veterinary Medicine, resulting in projected halving of Pharm Sci development costs relative to comparable Human Health projects- Took over leadership of two fragmented multi-disciplinary early candidate management teams (ECMTs) (consisting of clinicians, biologists, chemists, pharmacists, toxicologists, regulatory experts and project management), winning senior management support for unprecedented scientific proposals in a ground-breaking therapeutic area. - Member of Worldwide Pharmaceutical Sciences Leadership Team and Chemical R & D Line Council. Proposed, set up and chaired “Succeeding Through People” subgroup, delivering simple but effective mechanisms for leveraging the scientific expertise across global Chemical R & D.

- Appointed Section Head, then Manager, then Director of increasing numbers of Chemical R & D laboratory staff at Sandwich.- Completed successful regulatory submissions for new drugs in EU, USA and Japan, including key leadership roles for eletriptan and selamectin.- As a leading member of the CRD Management Team, made major contributions towards a doubling of headcount to 120 in a 3 year period, and the introduction of new specialist functions including laboratory automation and operations support. Facilitated pre- and post-merger staff motivation and deployment. - Through personal initiative, created and chaired the Sandwich CRD team of senior chemists resulting in improved quality, flexibility and operational efficiency.- Chaired Sandwich Pharmaceutical Sciences Veterinary Medicine Portfolio Management Group (VMPMG) leading the delivery of UK based Vet Med projects.

- Identified, developed and scaled up manufacturing processes for new drug candidates, including one for which as Pharmaceutical Sciences Project Coordinator, led drug substance and drug product activities from Discovery through to successful commercialisation in record time (5 years).- Responsible for technical liaison with R&D staff at other sites in the UK and USA.

- Led a small laboratory team designing and synthesising new compounds for biological and pharmacological testing.