Slough, England, United Kingdom
I am a study director for stability studies, which are carried out according to GMP for a number of monoclonal antibody products and other recombinant proteins. Responsibilities include writing and reviewing protocols and reports and ensuring all the testing has been performed for each timepoint within the required timeframes. This role also requires the writing of quality records for deviations, change controls and out of specification investigations. I ensure the delivery of the timepoint updates to the customer meet the associated deadlines. My other main role is the subject matter expert for CE SDS within the stability team and a system owner of the CE SDS instruments. System owner responsibilities include performing audit trails, troubleshooting and training new system owners. Other tasks have included performing the data integrity risk assessment for the CE SDS systems and updating and reviewing the method, equipment and software SOP’s. I currently chair the weekly Local Quality Council meetings presenting to each of the Analytical Services group representives and Quality Assurance representative. As part of this, the department quality metrics are reviewed and trended and improvements discussed alongside any quality issues raised.
I was involved in the development and validation of the new platform method for CE SDS and responsible for rolling out the method to the stability group and performing the training. Previous responsibilities have included system ownership of the UV spectroscopy instruments. I performed laboratory techniques monitoring the stability of monoclonial antibodies and other recombinant proteins to support the shelf life assignment of products. Analysis techniques included peptide mapping, GP HPLC, CE SDS, icIEF, SDS PAGE. All laboratory techniques were performed and documented to a GMP standard.
I was responsible for the operation of the restaurant and bar within the hotel. This position gave me experience in communicating with a wide range of people, working as part of a team and taking on responsibility for others.
Final year research project (10 weeks) January - May 2010 Kinetic Characterisation of Stereochemically Specific Aldolases from a Hyperthermophilic Archaeon I investigated the kinetic properties and aided the purification of stereochemically specific aldolases from Sulfolobus solfataricus. The aldolase had undergone site directed mutagenesis, where amino acids in the active site were targeted, in order to improve its stereochemistry in the hope that it can be used on a large scale to form carbon-to-carbon bonds. It was therefore important to see the effect of these mutations upon the activity of the enzyme. My results highlighted that improved stereoselectivity barely affected the activity of one of the mutant aldolases, whereas the activity of another was greatly reduced. Undertaking this project I acquired technical skills involving biochemical assays, such as the thiobarbituric acid assay and the Bradford assay. Anion exchange followed by gel filtration was used to purify the wild type and mutant aldolase enzymes where I identified the fractions containing the protein using SDS gel electrophoresis. I gained experience analysing kinetic data obtained using Enzpack software. The project was assessed by written report and oral examination, giving me experience in scientific writing as well as communicating my ideas verbally.
Comparison of the Brain Uptake of Artemisinin-Based Antimalarial Drugs in Mice My placement year provided 10 months working in a research laboratory where I undertook my own project. I investigated the uptake of a class of antimalarials into the brain with reported neurotoxicity in animal models. I looked at the ratio of the parent drug and metabolite in the plasma and brain of dosed mice. My results found that entry across the blood-brain barrier is dependent upon administration route and vehicle. Technical work included finding formulations for various artemisinin based antimalarial drugs that were to be suitable for intravenous and intramuscular administration. My project required animal work where I used Swiss mice, performing intravenous and intraperitonal injections, cardiac punctures and brain harvesting. Another major part of my project involved the preparation and analysis of plasma and brain samples by LC/MS, followed by the interpretation of the results and reporting findings to supervisors. In addition to writing a 50 page report, I also presented a poster on the project to the Department of Biology and Biochemistry at Bath on my return. It provided an opportunity to work independently and learn a wide variety of lab skills. This fantastic experience gave me an insight into the world of pharmaceutical sciences and living abroad.