Expertise and Zeal: Management of CMC Development, Project Management, Labeling & Distribution Management, Validation, Commissioning & Qualification.
Una has 18 years experience in the Pharmaceutical / Biotechnology sector, with a foundation in Commissioning & Qualification and Project management for projects based in large multinationals, in Ireland and Belgium, including Pfizer, Amgen, Eli Lilly and Elan. In recent years, Una works as a CMC lead for management of CMC projects from concept at cell line development stage through to clinical material manufacture and supply chain activities. In the projects environment, Una worked closely with multidisciplinary groups including Quality Assurance, Operations, Regulatory Affairs, Engineering and Project Planning groups. She is an adaptable, innovative, enthusiastic and confident individual with good communication and management skills.
Having completed a BSc and MSc in Biotechnology in DCU, Dublin, Una acquired a Project Management (PMI) accreditation in 2009.