A drug discovery, preclinical development, and development scientist with over twenty-five years of leadership experience in applying biophysical, analytical, biochemical, bioengineering, and biological approaches to interdisciplinary research and development problems in the biopharma. and academic settings. Highly experienced at:• Analytical and Biophysical method development activities in support of CMC operations. • Method transfers from development to Quality Control, and clinical phase appropriate qualification and validation of methods.• Developing both analytical and cell-based potency assays in support of drug release and stability efforts.• Analytical and Biophysical approaches to molecule assessment, pre-formulation, and formulation development activities.• Stabilization of therapeutics in the liquid-, cryo-, and solid-states.• Developing novel analytical and biophysical approaches to enumerating and characterizing heterogeneous populations of cells, viruses, and extracellular vesicles. • Drug disposition analysis in support of PK/PD and drug delivery efforts.• Authoring and reviewing regulatory submissions.