Process Validation, Slough

Working within the commercialisation and process validation team.

As a consultant I have worked on a range of projects, including Excel CoG models, process engineering and market research. Biopharm Services has designed and developed a cost-of-goods model called BioSolve for the biopharmaceutical industry. Biosolve allows analysis of early stage processes, including financial and process analysis. In addition I have held the role of BioSolve Product Manager. As the Product Manager i worked alongside the Marketing Manager in managing existing clients, including renewals and customer support. I have also supported marketing activities and been activity involved in sales to new clients.

EngD BioChemical Engineering and Bioprocess LeadershipInvestigating the use of monoliths as a capture step in a VLP process.Areas of research included comparisons of monoliths with resin columns, lipid fouling and lipid removal techniques, and the effect of HIC ligands on the VLP during the chromatographic process.Published paper in Journal of Chromatography B (2012).Worked with BIA Separations, Slovenia.

As part of my EngD. programme I undertook some MBA electives.- Managing Change- New Technology Ventures- Managing the Growing Business

The role was in the upstream area, notably in the seeding of new batches. I trained new technicians in the seeding area. I was also trained in centrifuge and fermentation activities.I was also involved in writing and reviewing regulatory documentation, including deviations, IQ/OQs, SOPs and batch records.

Working in the upstream area at this small CMO. Was also involved in support other processing areas, including media preparation and DSP.Helped with the review of regulatory documentation , including batch records and SOPs.