Alexandra Beumer Sassi

Alexandra Beumer Sassi, PhD, RAC has a significant amount of work experience in the field of CMC and Quality, particularly in the life sciences industry. Alexandra is currently the Global Head CMC & Quality at Voisin Consulting Life Sciences (VCLS), where they provide strategic leadership and oversight of the Global CMC&Quality Unit. Alexandra is responsible for building and leading a multi-site and remote team, bringing in business leads, and turning leads into clients.

Prior to their current role, Alexandra was the Senior Director CMC & Quality at VCLS, where they built a high-performing US CMC team and consistently exceeded department targets. Alexandra also contributed to global CMC&Quality goals and delivered CMC and regulatory strategy for over 40 regulatory submissions, mainly for cell and gene therapy products.

Before joining VCLS, Alexandra worked as a Principal Scientist CMC Regulatory Consultant at Cardinal Health - Regulatory Sciences. In this role, they ensured optimal regulatory compliance for US Regulatory CMC programs and activities and provided regulatory strategy for regulatory dossiers.

Earlier in their career, Alexandra held various roles at GSK, including CMC Regulatory Affairs Executive, Investigator, and Principal Scientist. Alexandra provided regulatory support for biopharmaceutical drug product development, led CMC matrix teams, authored successful regulatory submissions, and performed biophysical characterization and formulation of biopharmaceutical compounds.

Alexandra has a strong educational background, with a PhD from the University of Pittsburgh and a post-doctoral fellowship at Magee-Womens Research Institute.

Alexandra Beumer Sassi, PhD, RAC earned their Doctor of Philosophy (PhD) degree in Pharmaceutical Sciences from the University of Pittsburgh in 2008. Prior to that, they obtained their Doctor of Pharmacy (Pharm.D.) degree in Pharmacy-Biochemistry from USP - Universidade de São Paulo, from 1992 to 1998. In addition, they hold numerous additional certifications, including the RAC-US certification from the Regulatory Affairs Certification Program, obtained in December 2017.