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Andrea Pless Location
West Chester, PA, US
Andrea Pless Work
Vice President Regulatory Affairs @ (January 2025 - Present)
Principal Consultant and Consulting Manager @ (July 2021 - January 2025)
Director, QC Biologics CMC @ (February 2018 - July 2021)
Sr Director, Validation and QC, Small Molecules CMC @ (September 2017 - February 2018)
Director, Validation and QC @ (April 2015 - September 2017)
Associate Director, Validation and QC @ (May 2013 - March 2015)
Analytical Chemist and Sr Analytical Chemist @ (July 1999 - May 2013)
Analytical Chemist @ (January 1996 - June 1999)
Andrea Pless Education
University of Florida
PhD (Analytical Chemistry)
1991-1995
University of Florida
BS (Chemistry)
1987-1991
Andrea Pless Skills
Method Development
Pharmaceutical Industry
GMP
Quality Control
HPLC
Gas Chromatography
Chemistry
LC-MS
Validation
Analytical Chemistry
Molecular Biology
Biotechnology
Drug Development
Technology Transfer
SOP
FDA
Assay Development
U.S. Food and Drug Administration (FDA)
Formulation
V&V
Regulatory Submissions
Corrective and Preventive Action (CAPA)
Change Management
Zeta Potential
CMC development
Compliance
Characterization
Leadership
u.s. Food and Drug Administration Fda
Project Management
Microsoft Excel
Development
Analysis
Analytical Skill
Lc Ms
u.s. Food and Drug Administration
Andrea Pless Summary
Andrea Pless, based in West Chester, PA, US, is currently a Vice President Regulatory Affairs at SSI Strategy. Andrea Pless brings experience from previous roles at NDA Group - an SSI Strategy Company and Teva Pharmaceuticals. Andrea Pless holds a 1991 - 1995 PhD in Analytical Chemistry @ University of Florida. With a robust skill set that includes Method Development, Pharmaceutical Industry, GMP, Quality Control, HPLC and more. Andrea Pless has 4 emails and 1 mobile phone numbers on RocketReach.
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