Director, Manufacturing and CMC Operations @ (May 2020 - January 2022)
Director Program Management @ (September 2019 - April 2020)
Director, Global Injectable Drug Delivery Services @ (February 2016 - September 2019)
CMC Strategy and Program Management @ (September 2014 - February 2016)
Senior Program Manager, Product Development (Technical Fellow) @ (June 2012 - September 2014)
Program Manager, Pharmaceutical Process Development @ (January 2009 - June 2012)
Project Manager of Product Development @ Brookwood Pharma/Surmodics Pharma (January 2005 - January 2009)
Research Engineer @ (March 2003 - January 2005)
Danielle Clay Education
Ohio University
BS (Chemical Engineering)
University of Colorado Boulder
PhD (Chemical Engineering)
Villanova University
Master's (Project Management)
Danielle Clay Skills
Controlled Release
Microspheres
Pharmaceutical Project Management
Biodegradable Polymers
Pharmaceutical process development
Drug Delivery
CMC development
Combination Products
Product Development
Process Optimization
Extrusion
Process Simulation
Formulation
Leading Development Teams
Cross-functional Team Leadership
cGMP manufacturing
Polymers
Pharmaceutical Industry
IND
GMP
Regulatory Submissions
CMC
Drug Development
FDA
R
Design of Experiments
Pharmaceutics
Program Management
Validation
Technology Transfer
Medical Devices
Clinical Development
R&D
Sales
Engineering
Strategy
Cross Functional Team Leadership
SQL
Management
Research
Services
Research and Development
Danielle Clay Summary
Danielle Clay, based in Birmingham, AL, US, is currently a Executive Director, CMC Operations at BioCryst Pharmaceuticals, Inc.. Danielle Clay brings experience from previous roles at BioCryst Pharmaceuticals, Inc., Sollis Therapeutics, Evonik and Takeda Pharmaceuticals. Danielle Clay holds a BS in Chemical Engineering @ Ohio University. With a robust skill set that includes Controlled Release, Microspheres, Pharmaceutical Project Management, Biodegradable Polymers, Pharmaceutical process development and more. Danielle Clay has 4 emails and 2 mobile phone numbers on RocketReach.
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