Two New QP's Jopin the Biotec Team
11th August 2008
Biotec Services International Limited expands its team of registered Qualified Persons to help meet demand for its pharmaceutical services. The decision to employ Alan Smith and Ken Caldicott as consultants follows the rapid and continual growth of the company over the past few years and expands the QP team from three to five.
He previously spent 20 years with Parke-Davis Research, a division of Warner-Lambert, where he managed the analytical chemistry department and later took on responsibility for Quality Assurance. Ken then moved to Penn Pharmaceuticals where he worked for 13 years in a number of roles, including Chief Scientific Officer.
Dr Caldicott now operates his own consultancy business providing QP and CMC regulatory and strategy advice to many international clients including Japan and the US and can offer Biotec’s clients advice on CMC strategy for clinical trials supplies. The second QP to join the company is Alan Smith, a chartered chemist and Qualified Person with extensive quality and business experience within the pharmaceutical industry both in the UK and internationally. Alan has worked for The Wellcome Foundation, Glaxo Welcome, Glaxo Smith Kline, Aventis and his own company QED-QED ltd, in which he is director and consultant. During Alan’s 20 years of experience he has initiated a new cytotoxic production facility resulting in successful MCA and FDA inspections, he has project managed the transfer of key products to external manufacturers including the Third World and he has established a quality and compliance index that led to a significant improvement in inspection readiness status in one year. Marc Weinzweig, MD of Biotec commented “Biotec will greatly benefit from both Alan and Ken’s extensive and impressive knowledge and experience and we are very pleased to have them both as part of the team”.
In addition to the appointment of two Qualified Persons to the team at Biotec, Sarah Coram also joins as Operations Manager, a position recently created as a result of the increased volume of clinical trials being handled at Biotec and Jeremy Martin moves to the newly created role of Planning Manager in order to plan and schedule the import, labelling, assembly and logistics operations.
Marc Weinzweig comments, “The expansion of our QP team and the newly created position of Operations Manager and Planning Manager for Sarah and Jeremy marks a significant move for Biotec. The company is growing rapidly with the demand for our clinical trial services. We are currently running in excess of 80 clinical trials for our clients, but with Alan, Ken, Sarah and Jeremy onboard and our new state of the art facilities we will be able to take on a great deal more”.
“I have ambitious plans to make Biotec one of the largest pharmaceutical out-sourcing companies specialising in temperature sensitive pharmaceutical drug trials in Europe”.
Biotec Services International Limited was established in 1997 and works on behalf of global pharmaceutical companies, many located outside the EU, looking to conduct clinical trials and to market products in Europe.
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