Dynamic Project Manager, with rich and varied scientific experience. A strong communicator, adept at interacting with a broad church of colleagues, collaborators and customer. Highly analytical and proven to deliver innovative solutions, whilst working to challenging timelines. Now seeking new opportunities to thrive, contributing to a vibrant progressive organisation, in a sociable team, whilst continuing to learn and develop.
CMC Project Manager
Since February 2013
July 2009 --- February 2013
Technology development: • Formulation of biopharmaceuticals in Stabilitech’s proprietary excipients to enhance storage stability in both liquid and lyophilised settings. • Exemplification of Stabilitech’s existing (generation 1) excipients for stabilisation of viral exemplars (Adenovirus, MVA). • Responsible for adapting technology to stabilisation of biopharmaceuticals (cytokines, small polypeptides, mAbs, Fabs, fusion proteins). • Developed lyophilisation cycles for Stabilitech’s excipients, and high sugar formulations. Assay development • Adapted and validated cell proliferation assays (XTT based) for TNF, anti-TNF, and G-CSF. • Tested HPLC analytics for monoclonal antibodies, calcitonin, and G-CSF, including SEC, RP, IEX and monolithic. • Validated TCID50 and plaque assays for Adenovirus, Measles, and MVA. Intellectual property • Identification, and screening of novel excipient candidates using (Design of Experiments) DoE principals. • Exemplification of excipients for IP filings and proof of concept studies for collaborators. • Drafting patent reports, and edited and advised on patent applications (listed as inventor in a number of patent applications). Contract Research • HPLC assay validation (SEC and RP) on external contract developing thermal stable formulations of monoclonal antibodies for a major biopharmaceutical company. • Liaised with CROs. Mentoring • Supervised and trained junior scientists. • Led the introduction of DoE principals to formulation optimisation, developed template experimental designs for other projects and supervised their implementation and advised on their analysis. Recognised as lead company expert on MODDE. • Drove introduction of ICH testing principals and adoption of Arrhenius projections. General • Attended conferences for networking & presentation of company data. • Prepared reports and slides for internal company communications, as well as for clients and IP lawyers. • Wrote & reviewed QA documents.
Postdoctoral Research fellow
October 2006 --- October 2008
October 2006 --- October 2008
April 2006 --- September 2006
October 2000 --- February 2006
Marie Curie Training Fellow
October 2003 --- August 2004
Ph.D. in Insect Virology from University of Greenwich in 2006
Marie Curie Training Fellowship in Functional Genomics and Biodiversity in from Wageningen University in 2004
B.Sc. in Genetics from Cardiff University / Prifysgol Caerdydd in 2000