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 in large protein parenteral products.
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-Womens 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.