United Kingdom
Assessor of clinical trial authorisation applications involving a wide range of chemical and biological/biotechnological investigational medicinal products.
Assessor of clinical trial authorisation applications involving a wide range of chemical and biological/biotechnological investigational medicinal products.
• Deputy Study Director for the batch release control testing for HPV, HBV, Rabies and JEV vaccines, and Immunological Products, developing, implementing, and maintaining test methods to UKAS accreditation for ISO/IEC 17025:2017. • Responsible for facilitating the technical transfer of new methods from manufacturers to the control testing laboratory and establishing the review of product Summary Lot Protocols and test results in preparation for the release certification for the UK or Global market. • Deputy Product Supervisor for multiple WHO International Standards, reference/working reagents and IVD products, complying to ISO 13485 and the new IVDR. Assisting with the organisation of international collaborative studies in the establishment of these standards.
Main responsibilities included, - Investigating and developing new and improved International Standards and methodologies for the standardization of new inactivated poliovaccines based on the use of live-attenuated virus strains as opposed to the wild virulent strains used in current inactivated poliovaccines. - Supporting the area of surveillance for poliovirus as part of the Global Polio Laboratory which, focuses on the characterization of polio and non-polio enteroviruses isolated from different surveillance activities with an aim to develop new and improved methodologies for the rapid detection of wild and vaccine-derived polioviruses.
Providing Analytical Services within the Trace Analysis laboratories for Sellafield Ltd. Using ICP-OES for the determination of elemental impurities in a variety of different radioactive materials.