- I am a pharmacist registered with the UK’s General Pharmaceutical Council (GPhC) and a member of the Royal Pharmaceutical Society of Great Britain (MRPharmS). I am also a Fellow of the Royal Society of Chemistry (FRSC) and a Chartered Chemist (CChem).
- I have over 24 years working experience in major-Pharma firms (B-MS, AZ, SA) as well as smaller, development-oriented companies. That experience has included
- the development and manufacture of solid & liquid oral dosage forms, inhalation products, topical semi-solids & sterile products.
- the development of conventional pharmaceutical dosage forms, biotechnology products, natural product materials, generic pharmaceuticals and CE-marked medical devices.
- significant experience in pharmaceutical R&D in areas as diverse as biopharmaceutics, nanoparticle engineering, drug solubility theory and natural product characterisation.
- Based on this I have compiled the CMC content of IND/IMPD and (A)NDA/MAA submissions as well as ISO 13485 submissions for medical devices. This has involved face-to-face meetings with FDA, EMA and various EU national agencies.
- Additionally, I have led teams developing & applying analytical test and managed intra-site & inter-site technology transfers. In this I have become proficient in the use of business tools such as Kepner-Tregoe problem solving & decision-making, KPI, Lean & 6-Sigma.