2020 -2022 Director, Manufacturing and CMC Operations @
2019 -2020 Director Program Management @
2016 -2019 Director, Global Injectable Drug Delivery Services @
2014 -2016 CMC Strategy and Program Management @
2012 -2014 Senior Program Manager, Product Development (Technical Fellow) @
2009 -2012 Program Manager, Pharmaceutical Process Development @
2005 -2009 Project Manager of Product Development @ Brookwood Pharma/Surmodics Pharma
2003 -2005 Research Engineer @
Danielle Clay Education
University of Colorado Boulder
PhD (Chemical Engineering)
Villanova University
Master's (Project Management)
Ohio University
BS (Chemical Engineering)
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 PhD in Chemical Engineering @ University of Colorado Boulder. 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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