Wei Xu

About Wei Xu

PhD in Pharmaceutical Chemistry with 20+ years of leadership responsibility in small molecule and biologics drug product development spanning from discovery support to final market formulation definition. Contributed to the commercialization of multiple drug products (CANCIDAS, INVENZ, ISENTRESS, ISENTRESS HD, ZEPATIER, PIFELTRO, DELSTRIGO). Deep technical expertise in physical and chemical analysis of drug substance and drug product for a wide variety of dosage forms. Drove functional area strategy for materials/biophysical characterization to support early and late-stage development programs. Experience with authoring regulatory filings (IND and NDA). Leadership roles in multiple cross-functional CMC governess committees to provide oversight on different aspects of drug product development process. Contributed to broad small molecule CMC strategic initiatives including development milestones, risk assessment and processes improvement to facilitate project execution. 50+ publications, patents, presentations and consortium participation. Extensive talent development experience as a people manager and scientific mentor.

Experience

1. Distinguished Scientist

   Merck

   May 2020 — Present · West Point, PA, US

   drug delivery, materials and biophysical characterization for small molecule, biologics, and vaccine formulations, cmc project leadership, scientific strategy

Education

• The University of Georgia

  Bachelor's degree, Biochemistry

  1990 — 1992

• Fudan University

  Biochemistry

  1988 — 1990

• Purdue University

  PhD, Pharmaceutics

  1992 — 1997