Greater Oxford Area
During my scientific career I have learnt a great deal about the wide variety of biological systems and techniques. These have varied from cell culture investigating molecular biological mechanisms for DNA repair to the barcoding of primary human stem cells with the associated sequencing and analysis. I gained experience with process development and GMP manufacturing processes (including BMR and FMEA preparation) before going on to develop a new core facility at Oxford University. I gained leadership experience managing the AAV Process Development team at Oxgene before moving to manage the Production team at the Clinical BioManufacturing Facility to widen my skillset with GMP experience. During my career I have aimed to gain experience from basic research to production of clinical products giving me a good overview of the scientific process,
As GMP Production Manager I oversee a team of 6 to lead the programme of manufacturing of clinical grade products within the Clinical Biomanufacturing Facility. This involves planning of cleanroom activities, preparing all relevant SOPs and BMRs as well as ensuring all routine tasks required to maintain the cleanrooms are performed. The CBF acts as bridge from academic protocols to the production of clinical grade material, this requires a strong academic and industrial mind set in order to translate processes/materials from research laboratories into ones that will pass regulatory inspection. I also complete all relevant Quality Management System documentation (CAPAs, Change Controls, Deviations etc...) to maintain compliance with relevant regulatory bodies.
At Oxgene I led the Adeno/AAV Upstream Process Development team as part of the wider Process Development group. The team consists of 5 members who perform AAV and AdV production and process development at small scale using the ambr15 and Eppendorf bioreactor systems (up to 10L), Hamilton Robots and shake flasks. This position has allowed me to gain wider knowledge of AdV and AAV systems, small scale DSP options while also developing my managerial skills and giving me a greater insight into commercial vector development. Alongside my team management duties I am also involved in project feasibility and costing in collaboration with business development and project management teams. I also directly face clients for technical discussions and data reporting from project kick off to data summaries/reports and project completion.
At the Weatherall Institute I have set up a core viral production and screening facility in order to generate lentiviral, retroviral and AAV preparations for routine research as well as custom CRISPR screening (from small scale to genome wide screens). This involves managing projects from inception and experimental planning to data analysis while maintaining detailed records of the production process. As part of the service offered I discuss viral backbone selection, cloning strategies, transduction approaches and data analysis with researchers in order to maximise scope of their project. To facilitate the screening I constantly develop the upstream and downstream processes for virus production and purification. These processes include both adherent and small scale (<1L) serum free suspension production paired with ultracentrifugation or chromatography purification.
In this position I was part of a team responsible for the development of scalable processes for the manufacturing of clinical gene therapy materials using bioreactors from manufacturers including TAP (AMBR15), Applikon and Sartorius . This involved a variety of quickly evolving technologies and the ability to rapidly familiarise myself with new scientific and regulatory areas.
Postdoctoral Research Associate in the lab of Professor Sherif El-Khamisy. This predominantly involved mammalian cell culture, transfection, protein purification and various PCR techniques. My work focused on post translational modification of DNA repair factors, this has included the design and optimisation of siRNA based screens with varying outputs (western blots and high content microscope imaging). I was also heavily involved in laboratory management and the teaching of new members of the lab.