Position: Lecturer in Pharmaceutical Technology and Pharmaceutical Projects Manager Duties and Responsibilities Since my return to DIT from NIBRT in 2007, I have spearheaded the development of partnerships in Singapore, with DPS Engineering, and Singapore Polytechnic I have continued to lecture Pharmaceutical Technology to MSc students, while also taking up the role of Dissertation Coordinator for the MSc in PQA and MSc in PVT students. In February 2009 I was appointed to the role of Pharmaceutical Projects Manager in order to develop DITs relationships with the Pharma Sector, in Ireland, Singapore and other overseas locations. I lead the Pharamaceutical Science and Regulatory research team and currently have Students studying for PhDs as part of this team. I have acted as a member/chair of several DIT Programme Accreditation panels, including Chairing the recently approved partnership with the Bristol and Brighton Institute of Modern Music (BIMM) and the accreditation of their BA (Hons) in Commercial Modern Music 2006-2007 (Career Break) National Institute of Bioprocessing Research and Training (NIBRT) Engineering Building University College Dublin Belfield Dublin 4 Position: Training Director Duties and Responsibilities I joined the senior management team of NIBRT in 2006 in the leadership role of Training Director. This team, together with the IDA and a consortium of 4 Academic bodies (DCU, ITS, UCD and TCD), founded NIBRT, a Research and Training institute designed to address the needs of the emerging Biopharmaceutical Industry, a sector the Government has identified as being strategically important to Ireland. Globally the Biopharmaceutical industry is restricted by skills shortages and as Training Director I developed for NIBRT a Training Policy that is designed to address the immediate skills shortage, and future bioprocessing education requirements, to secure the development of an knowledge based economy. The scope of my work included amongst other things: • Member of the NIBRT Board of Management • Leading the NIBRT Training team in the development and implementation of the Innovative NIBRT Training Strategy. • Marketing of NIBRT Training solutions to International client companies, including Centocor, Wyeth, Pfizer’s and other Large (Bio)Pharmaceutical companies • Management of the preparation and delivery of NIBRT Training Solutions • Ongoing leadership and management of the NIBRT Training Team, comprising of 2 direct reports, several contract trainers, and consortium member academics. • NIBRT representative at IDA led international and national industry and client meetings • Representing NIBRT at national and international conferences as speaker and exhibition event organinser. • Development and signing of Memorandum of Understanding between NIBRT and FAS • Leading the negotiation and agreement of licensing arrangements with ISPE • Technical Assessor for Government funding schemes 1996-2006 Dublin Institute of Technology School of Chemical and Pharmaceutical Sciences Kevin Street Dublin 8 Position: Programme Co-ordinator and Lecturer in Pharmaceutical Technology Duties and Responsibilities I joined the school of chemistry, DIT in 1996 as a lecturer in Pharmaceutical Technology after spending several years in the Pharmaceutical Industry as both a Validation Manager and Technical Service Chemist. My motivation for taking up an academic role was to: • Introduce Pharmaceutical Technology, Validation and Quality Assurance to the undergraduate courses offered by the school of chemistry, DIT • To develop specialist programs for the pharmaceutical sector, at Postgraduate Diploma and MSc level, which would bridge the gap for students qualifying in science disciplines to the specific requirements of the pharmaceutical and biopharmaceutical industry, especially in relation to regulatory, quality and validation issues The scope of my work included amongst other things: • Course Co-ordinator, MSc in Pharmaceutical Validation Technology. o I established a steering group with representatives from industry, academia and regulatory authorities who met over a 6 month period to develop this new course, which was validated by the DIT in December 2003.. • Course Co-ordinator, MSc in Pharmaceutical Quality Assurance, a course I developed and introduced to DIT in 1998. • Lecturer in Pharmaceutical Technology, Validation and Pharmaceutical Quality Assurance to undergraduate and postgraduate students • Research and Supervision of Research projects and Dissertations • Science faculty representative on the DIT postgraduate taught courses committee • Development of strategic alliances and collaboration with third party bodies, to identify, develop and market new programmes and research opportunities. o With the European College of Validation, I led their franchising of the MSc in Pharmaceutical Validation programme in 2003, which they offer as a distant learning programme, serving the European Pharmaceutical Industry o With DPS Engineering, I developed a partnership which led to the validation of an ordinary degree in the Validation of Medicinal Products, which should commence in September 2007. o With Groupe IMT, France, I organised the visit of over 100 French Students to DIT over several years from 1999 - 2003 1993-1996 Wyeth Medica Ireland Newbridge Co. Kildare Position: Validation Manager Duties and Responsibilities I joined Wyeth Medica Ireland at the start up of the Newbridge plant in March 1993 as a Validation Engineer and was promoted to Validation Manager within 5 months. I was responsible for the design, development and execution of the process validation of over 90 new products and the planning and co-ordinating the Equipment Qualification programme which was carried out by a contract company. My key objective was to establish a department and train staff to a level of competency such that they could execute the validation programmes that I had designed to meet the approval of international regulatorities. The success of this was confirmed in July 1994, the Irish Medicines Board brought a group of European Pharmaceutical Inspectors on a visit to the site in order to see the Validation Programme. As one of the first members of the processing department at Wyeth, recruited to fast track the start up of the manufacturing facility, I was a key member of the processing Management Team, which comprised of 4 other area managers, and myself reporting to the Processing Manager. Together this team successfully set-up operations, on time and on budget. The scope of my work included amongst other things: • Complete responsibility for the start-up of the validation department, which involved identifying the resources required, recruitment and training of personnel • On-going management, development and motivation of the validation department, which comprised of 4 validation engineers and 4 validation/processing operators. • Overseeing and approving the work of the Jacobs Engineering the contractor group employed to carry out the equipment and facility validation. • Design and execution of the Processing Validation programme for the start-up of the New facility, together with the introduction of Change Control procedure • Process Development / Optimisation and technical support for the manufacture of 7 billion tablets per annum • Liaising with various international Wyeth groups to co-ordinate new product introduction and address regulatory and Stability issues • Design and development of an statistical process control system • Set –up of the processing models of the MRPii system 1991-1993 Sterling Winthrop Ireland Dungarvan Co. Waterford Position: Technical Services Chemist Duties and Responsibilities I Joined Sterling Winthrop (Ireland) in April 1991, where I gained first hand experience of operating in a GMP environment in a World Class Manufacturing Facility. During my time in Sterling Winthrop I embarked upon intensive training programmes on Pharmaceutical Manufacturing, Quality Assurance and Regulatory issues. The scope of my work included: • Project manager with overall responsibilities for introduction of a wide range of new solid dose medicinal products. This involved liaison with worldwide R&D and Marketing functions • Process development, optimisation and scale-up • Equipment and Packaging Qualification and process validation • Member of the Business Development and Customer Service Group with responsible for Kenya market • Writing of technical reports and Documents • Annual Product Reviews 1990-1991 CDVEC Cathal Bruagha Street Dublin 1 Position: Temporary Lecturer in Industrial Chemistry

Pharmaceutical Science and Regulatory