Barbara Butler Email & Phone Number
Senior Director, Regulatory Affairs CMC @ Damora Therapeutics
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Barbara Butler Location
- Pottstown, PA, US
Barbara Butler Work
- Senior Director, Regulatory Affairs CMC @ (July 2026 - Present)
- Director, Global RA CMC @ (January 2024 - July 2026)
- Director, Regulatory Affairs CMC @ (March 2023 - January 2024)
- Associate Director, Regulatory Affairs CMC @ (December 2021 - March 2023)
- Associate Director, Global Specialty CMC RA @ (January 2018 - December 2021)
- Associate Director, CMC Project Management @ (January 2015 - January 2018)
- Associate Director, CMC Program Management @ Morphotek, Inc. (December 2012 - December 2014)
- Senior Project Manager @ Morphotek, Inc. (July 2007 - December 2012)
- Project Manager @ AppTec (January 2006 - January 2007)
- Project Manager @ Lampire (January 2001 - January 2006)
Barbara Butler Education
- La Salle University
MBA (Organizational Management)
2004-2007 - Delaware Valley University
BS (Small Animal Science)
1998-2002 - The Wharton School
MS (Biotech Engineering)
2008
Barbara Butler Skills
- 21 CFR
- 21 CFR Part 11
- Analytical Method Validation
- CAPA
- CMC development
- Celiac Disease
- Cell Culture
- Chemistry, Manufacturing, and Controls
- Clinical Development
- Communication
- Dossier Preparation
- ELISA
- EMEA
- FDA
- Formulation Chemistry
- GMP
- IND
- Leadership
- Mammalian Cell Culture
- Molecular Biology
- Nanoparticles
- Process Control
- Process Development
- Process Simulation
- Process Validation
- Project Management
- Protein Purification
- Regulatory Affairs
- Regulatory Requirements
- Regulatory Strategy Development
- Report Writing
- SFDA
- Servant Leadership
- Sop
- Stability Studies
- Teamwork
- Technical Project Managment
- Technology Transfer
- Trackwise
- V&V
- Vaccines
- Vendor Management
- Business Analysis
- Microsoft Word
- Change Management
- Chemistry
- Manufacturing
- Controls
- Process Improvement
- Project Planning
Barbara Butler Summary
- Barbara Butler, based in Pottstown, PA, US, is currently a Senior Director, Regulatory Affairs CMC at Damora Therapeutics. Barbara Butler brings experience from previous roles at Takeda, CRISPR Therapeutics and Teva Pharmaceuticals. Barbara Butler holds a 2004 - 2007 MBA in Organizational Management @ La Salle University. With a robust skill set that includes 21 CFR, 21 CFR Part 11, Analytical Method Validation, CAPA, CMC development and more. Barbara Butler has 3 emails and 2 mobile phone numbers on RocketReach.
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