Primarily involved in lead roles in Technology Transfer, Scale-up, Validation and Filing of new API products en route from Development to Manufacturing in a cGMP environment and developed under Quality by Design (QbD). Recent responsibilities 09-10 Project Leader • Results-oriented Project Leader for site activities in creation of the CMC section of dossier of a new drug Marketing Authorisation Application (submitted Feb 2010 to the European Medicines Agency). • Authored the Manufacturing Description for this dossier, which was developed under QbD. • Coordinated multifunctional reviews during drafting of the CMC section. • Led site technical and cross-functional activities for a successful 6 day project Corporate Pre-Approval Inspection. 09-10 Lead Chemist • Lead chemist on a concurrent QbD TT project with a high incorporation of PAT. • Designed and trialled the manufacturing procedure based on development documentation. 07-09 Lead Chemist • Led a team of 5 chemists for the successful process validation of a new drug manufacture • Mentored and upskilled new starters and team members to quickly and efficiently take on project and campaign work • Managed validation campaign at third party manufacturers in Switzerland and responsible for their production of outsourced early steps. • Presented with an Achievement Award for this work. • Developed and implemented the Process Verification procedure which has been adopted site-wide for monitoring manufacturing campaign performance and identifying trends. 07 Mfg Support • Chosen to support a sister site in Puerto Rico for three months in 2007 and moved there to do so • Main duties were to provide on-site manufacturing support for large scale production projects • Supported small scale manufacturing of cytotoxic products, in high containment facility in Dublin • Developed and implemented a mother liquor recovery procedure for a cytotoxic product