As a Director, Chemistry, Manufacturing and Controls (CMC) at VCLS, Jennifer 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 and cell and gene therapy products.
Jennifer has over 12 years of experience in the pharmaceutical/biopharmaceutical industry. She brings significant expertise in product development including quality control, formulation, product manufacturing and validation, stability, and CMC matrix team leadership. Jennifer has worked with a variety of dosage forms and molecules, with particular emphasis in large protein parenteral products.
As a consultant, Jennifer assists clients with CMC development strategy, including accelerated development for cell and gene therapies, scientific advice, regulatory submissions, and technical protocols and reports.
Prior to joining VCLS, Jennifer was first a Principal Scientist and then an Investigator at GlaxoSmithKline, Biopharmaceutical CMC. She was responsible for process development and technology transfer of a biopharmaceutical combination product. She was the drug product lead on several Phase I through Phase 3 projects and authored CMC sections for US and EU regulatory submissions for biopharmaceutical products. In addition to regulatory submissions, Jennifer is a well experienced CMC technical writer.
Prior to her role as Principal Scientist, Jennifer completed her post-doctorate work at GlaxoSmithKline investigating opalescent monoclonal antibody formulations. She has published a number of articles in peer-reviewed journals.
Jennifer received her PhD in Chemical Engineering from the University of Delaware. Her dissertation work was on developing a nucleated polymerization model for protein aggregation. She received her Bachelor’s degree in Chemical Engineering from Florida State University.
Jennifer is member of the Alliance for Regenerative Medicine.
Jennifer is based in VCLS offices in Cambridge, MA.