Macovei Lilia

About

Lilia Macovei is a Bioanalytical Principal Investigator/Senior Research Scientist in the Department of Biomedical Design. Lilia earned her Ph.D. in Molecular Biology from the University of Agricultural Sciences and Veterinary Medicine, Cluj-Napoca, Romania, and subsequently completed postdoctoral research studies in Microbiology, Infectious Diseases, and Immunology at Forsyth Institute/Harvard Medical School. Lilia’s expertise includes regulated and non-regulated bioanalytical support for Pfizer’s biotherapeutic product portfolio. She has worked on the development and validation of pharmacokinetic and immunogenicity (ADA and cell-based neutralizing antibodies) assays for non-clinical and clinical studies. She has experience across a broad range of biotherapeutic modalities and diseases, including monoclonal antibodies, fusion proteins, bispecifics, antibody-drug conjugates, various viral vector platforms, and chimeric antigen receptor T-cell (CART) therapies. Experienced scientist with a background in the pharmaceutical and biotechnology industries in drug development. Proven strategic leadership and technical expertise in supporting bioanalysis of preclinical and clinical studies, immunogenicity assessments, biomarker strategy, and translational development for diverse therapeutic modalities (large molecules, antisense oligonucleotides (ASO), and gene and cell therapies) in rare diseases, cardiovascular, immuno-oncology, and neurological indications. Excellent communication, problem-solving, and time management skills with a proven track record of success in leading cross-functional teams or working in a fast-paced, matrix environment. Highly familiar with GxP (ICH/FDA/EMA) compliance guidelines and industry best practices.