Sharon L. Young, Ph.D.

Area of Expertise:

Sharon L. Young, Ph.D.

Senior Consultant

Sharon Young provides developmental, technical, laboratory, quality, operational, and regulatory support to the healthcare products industry.  She specializes in the areas of analytical/method development; quality control (QC) and stability testing; cell-based potency assays; process validation; active pharmaceutical ingredient (API) development; chemistry, manufacturing and controls (CMC) regulatory submissions; GXP compliance; and quality systems.  Additionally, she provides support including standard operating procedure (SOP) authoring, technical and analytical method validation report generation, analytical method data trending, analytical equipment validation support, data integrity compliance, and laboratory inspection readiness.  Prior to joining SciLucent, Sharon worked at Patheon, part of Thermo Fisher Scientific, where she was involved in numerous early-, mid-, and late-stage development and tech transfer projects for a variety of mAbs, enzymes, biosimilars, Fc fusions, bispecific antibodies, and other recombinant proteins.  She has extensive experience in test method development and validation, cell-based potency assays, analytical cell bank preparation, comparability and forced degradation studies, QC product testing, QC laboratory audits and inspection readiness, and data integrity compliance.  Sharon has a Ph.D. in Molecular & Cellular Biology from Washington University and a B.S. in Biology from The George Washington University.  Sharon has been a member of the SciLucent team since 2021.