Alexandra_Beumer Sassi

Alexandra Beumer Sassi

Voisin Consulting Life Sciences

Dr. Beumer Sassi is a Senior Director, Chemistry, Manufacturing and Controls at Voisin Consulting Life Sciences (VCLS). Dr. Beumer Sassi has over 20 years of experience in pharmaceutical/biopharmaceutical industry and consulting services. At VCLS, Dr. Beumer Sassi is responsible for the strategy and technical content of projects involving the CMC development of Biologics, Cell and Gene therapy products. She is the head of the CMC regulatory team in the US built to assist clients on bringing safe and quality innovative products to patients. She actively contributes in the authoring and review of regulatory dossiers from early to late stage, and interactions with EMA and FDA.

Prior to joining VCLS, Dr. Beumer Sassi has held different positions of growing responsibilities. Dr. Beumer Sassi was a CMC Regulatory Executive at GlaxoSmithKline, where she developed CMC strategy and coordinated regulatory submissions for Marketing Authorization in US, EU, Japan, and emerging markets. At GSK, she also held several roles starting as a Principal Scientist and later on as an Investigator in BioPharmaceutical R&D department working with formulation, characterization, and development of monoclonal antibodies.

Dr. Beumer Sassi received her PhD in Pharmaceutical Sciences from the University of Pittsburgh, and her Pharmacy degree from the University of Sao Paulo, Brazil. She completed her post-doctoral studies at Magee-Womens Research Institute in Pittsburgh. Dr. Beumer Sassi holds a US Regulatory Affairs Certification. She is an active member of the Alliance for Regenerative Medicine (ARM), the Regulatory Affairs Professional Society (RAPS), CASSS, and the Women in Bio organization.