As a Director, Chemistry, Manufacturing and Controls 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 biologicals.
Alex has over 16 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.
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. 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.