Niamh O’Dwyer

Director Global Validation & Technical Standards, Manufacturing, Alexion Pharma Int. Operations UC

Niamh has over 20 years’ experience in the Pharmaceutical industry and has previously worked with both Pfizer and Jacobs Engineering. She has worked in both site and Global roles providing strategic validation and technical transfer guidance. Niamh has worked on all aspects of the Validation process including Process, Cleaning, Equipment Validation and Continued Process verification in the areas of Drug Substance, Drug Product, Small Molecule API and Oral Solid Dosage. During her career Niamh has worked on several bioprocess start-up projects. Niamh has a B.Sc. in Science (Microbiology/Biochemistry) from University College Dublin, a M.Sc. in Pharmaceutical Validation Technology from Dublin Institute of Technology and a M.Bs. from the Irish Management Institute / University College Cork