Edward Balbirnie has over 30 years international experience in senior management positions in biopharmaceuticals. Edward had worked in several start-ups (Polpharma Biologics in Poland, GamaMabs, IDM and Cellectis in France, Trinity Biotech in Ireland) to ‘hands-on’ commercial scale/Big Pharma activities (Pfizer and Elan in Ireland, Novartis in Switzerland, GanLee in China). He has a strong technical expertise, having worked in the areas of cell therapy, stem cells, gene therapy, monoclonal antibodies, recombinant proteins, vaccines, biosimilars, transgenic proteins, antibody-drug conjugates and immunodiagnostics. Edward holds a PhD in Medical Microbiology from University College Dublin and is a Qualified Person, holding a M.Sc. in Pharmaceutical Manufacturing Technology from Trinity College Dublin. Edward supports BIOMUNEX as an expert for CMC development and manufacturing.