Maria Rathmann Sørensen, PhD is a regulatory CMC lead for cell therapy development projects at Novo Nordisk. She has 15 years of experience with R&D and CMC from working in academia and the biopharmaceutical industry. She joined Novo Nordisk in 2016 and has worked on various CMC development activities including virus safety of biologics/CGT, virus- and mycoplasma testing, raw material risk evaluation, QC method development (in vitro assays and molecular-biological methods), and regulatory science focusing on CMC development of cell therapies and conventional biologics. Maria Rathmann Sørensen has a Master of Science in Biology-biotechnology and earned her PhD in Immunology in 2008 from Copenhagen University. She worked as a postdoctoral researcher within immunology and virology research and vaccine development at the Statens Serum Institut and the Danish Technical University. She volunteers as a review editor for the scientific journal Frontiers in Immunology and is the (co)author of 18 peer-reviewed scientific publications.