I am a pharmaceutical biotechnologist leader and scientist with extensive cross-functional experience in biopharmaceutical development, manufacturing, CMC, regulatory affairs, and supply chain management.My expertise lies in the development and manufacturing of liquid and lyophilized dosage forms for a wide range of biologics, including monoclonal antibodies, bispecifics and engagers, antibody-drug conjugates, cell and viral vectors, nucleic acids, recombinant therapeutics, vaccines, nuclear medicine, and peptides.I bring extensive CMC leadership experience, spanning from pre-clinical to late-stage development, including life-cycle management and commercial support. I have made significant contributions to CMC sections and have authored several regulatory submissions and patents. Additionally, I excel in managing and mentoring teams of scientists and associates.Key strengths in the technical domain include parenteral formulation and drug product development, Chemistry, Manufacturing, and Controls (CMC), aseptic processing of drug products, and the management of Contract Development and Manufacturing Organizations (CDMOs). I also have expertise in the development and manufacturing of dry dosage forms.
Listed skills include Formulation, Biopharmaceuticals, Biotechnology, Protein Chemistry, and 17 others.