Sara Wu
Executive Director of Pharmaceutical Development at Celcuity
- Role
- Executive Director of Pharmaceutical Development at Celcuity
- Location
- Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Sara Wu
Have more than 20 years of experiences in drug product formulation development and manufacturing at various development stages including preclinical, clinical, NDA registration and preparation of commercial launch. Lead drug product development, manufacturing, analytical development/validation Work closely with regulatory affairs, clinical, commercial and Quality. Serve as project leaders with timeline and budgetary responsibilities. Provide RFP for outsource work and negotiate contract scope and cost (for up to a few million dollars). Manage various CDMO for drug product development, manufacturing and analytical method development/validations. Work together with regulatory and prepare regulatory submission documents for IND, IMPD, NDA and MAA.
Experience
Executive Director of Pharmaceutical Development
Nov 2021 — Present · Minneapolis, MN, US
Education
The University of Kansas
Ph.D, Medicinal Chemistry
1993 — 1997
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