Performing CQV activities alongside process upscale for small to large scale LNP production

Working on behalf of GSK in the Process Supply Chain site in Ware UK. engaging in validation activities for GxP and non-GxP systems

Planning and execution of CQV activities in the pharmaceutical industry, typically within sterile manufacturing. Re-qualification of clean utilities, equipment and production lines, including HVAC, Compressed air, WFI, Clean steam, Sterilisers, Mixing Tanks, Fill/Seal lines. Preparing and executing a range of protocols including URS, QP, IQ, OQ, PQ protocols and component/system impact assessments. Performing CQV activities to GMP standards following Ph. Eur., ISO, EudraLex, ASME-BPE guidelines

Performed thesis on characterising the loading and release efficiency of macromolecular drugs in novel liposome systems, achieving a distinction for lab based dissertation.

Researched the 'Greasomatic', a lubricant dispersion unit produced at Wymark Ltd, improving the chemistry and manufacturing process involved.Presented findings in a detailed report as well as presenting key details to the managers of Wymark Ltd. Recommended new equipment and generated a new standard procedure for the company to follow. This resulted in a 40% increase in rate of production and drastic reduction in the number of faulty products.

* A paper has been published on the research.BP sponsored research project investigating the production of biofuels from seaweed. Experiments involved microwave pyrolysis and standard fermentation to produce biofuels comparing the calorific value and structure and analysing the possible future use. Gained experience using different pieces of analytical equipment, such as: Thermogravimetric analysis, Bomb calorimetry, dielectric analysis, ion chromatography, and HPLC. *Kostas, E. T., Williams, O. S. A., Duran-Jimenez, G., Tapper, A. J., Cooper, M., Meehan, R. & Robinson, J. P. (2019) Microwave pyrolysis of Laminaria digitata to produce unique seaweed-derived bio-oils. Biomass and Bioenergy. 125 41-49. Available from: https://www.sciencedirect.com/science/article/pii/S0961953419301217.