As a Director, Chemistry, Manufacturing, and Controls (CMC) at VCLS, Alexandra (Alex) is responsible for providing CMC and regulatory consulting services to clients to help them take their products from early clinical phases to marketing authorization, particularly for biological, cell and gene therapy products.
Alex has over 17 years of experience in the pharmaceutical/biopharmaceutical industry and consulting services. She brings significant expertise in analytical method development, quality control, formulation development, product manufacturing scale-up, stability, and CMC matrix team leadership. Alex has worked with a variety of dosage forms and molecules, with particular emphasis on large protein parenteral products.
Prior to joining VCLS, Alex was a Regulatory Affairs CMC Consultant at Cardinal Health Regulatory Sciences. She was responsible for providing regulatory strategy and assisting clients on regulatory submissions. She was responsible for a range of products including biopharmaceuticals, gene therapy, cell therapy, combination products, and medical devices.
Prior to joining Cardinal Health, Alex was a CMC Regulatory Executive at GlaxoSmithKline, where she developed CMC strategy and coordinated regulatory submissions for Marketing Authorization in the US, EU, Japan, and emerging markets. Previously to her regulatory role, Alex authored several CMC sections for Clinical Trial Applications for biopharmaceutical compounds. Prior to GSK, she held several positions at a generic pharmaceutical company in Brazil.
Alex received her PhD in Pharmaceutical Sciences from the University of Pittsburgh, School of Pharmacy. Her dissertation work was with pre-clinical and formulation development of biopharmaceutical microbicides. She received her Pharmacy degree from the University of Sao Paulo, Brazil. She completed her post-doctoral studies at Magee-Women’s Research Institute. Alex is also US RAC certified and is a member of the Regulatory Affairs Professional Society (RAPS), the Association of Women in Bio, and the Alliance for Regenerative Medicine.
Alex is based in VCLS offices in Cambridge, MA.