Ashley returned to BioTechLogic in 2021 after two years at COUR Pharmaceuticals, serving most recently as the VP of Ops and Quality.
Analytical Development
Quality Assurance
Regulatory Affairs
Ashley returned to BioTechLogic in 2021 after two years at COUR Pharmaceuticals, serving most recently as the Vice President of Operations and Quality. Ashley supports clients in a variety of areas, with a focus on analytical, quality, and regulatory considerations. She provides expert advice for the development, qualification, and validation of analytical methods pertaining to biopharmaceutical analysis and CMC development used throughout the drug development and approval process under GxP guidelines. She also provides expert advice related to establishing specifications and their associated justifications, the generation of comparability plans and protocols, analytical method transfer and validation, and SOP generation, compliance, and biosimilarity demonstration. She also has extensive experience in authoring and performing expert reviews of the Pharmaceutical Quality/CMC sections (Module 3) of the eCTD for regulatory submissions.
Before COUR and BioTechLogic, Ashley was a Research Chemist in the Office of Testing and Research at the US FDA. While with the agency, she served as an expert in analytical method development, qualification, and validation, specializing in mass spectrometry, chromatography, and spectroscopy. She has authored 20 peer-reviewed publications. Prior to joining FDA, Ashley was a Chateaubriand Fellow of the Office of Science of Technology of the Embassy of France in the United States at École Polytechnique in Palaiseau, France. She has a BA in Chemistry from Pomona College in Claremont, California, and a PhD in Chemistry from the University of Arizona. She has also taken post-graduate courses at Arizona State University, with a focus on statistics for biological systems.
Cour Pharmaceuticals Development Company
Vice President of Operations and Quality
Director of Quality
US Food and Drug Administration, CDER, Division of Pharmaceutical Analysis
Research Chemist
Chemist
ORISE Fellow
University of Arizona
PhD in Chemistry (Analytical)
Pomona College
BS in Chemistry
Ashley returned to BioTechLogic in 2021 after two years at COUR Pharmaceuticals, serving most recently as the Vice President of Operations and Quality. Ashley supports clients in a variety of areas, with a focus on analytical, quality, and regulatory considerations. She provides expert advice for the development, qualification, and validation of analytical methods pertaining to biopharmaceutical analysis and CMC development used throughout the drug development and approval process under GxP guidelines. She also provides expert advice related to establishing specifications and their associated justifications, the generation of comparability plans and protocols, analytical method transfer and validation, and SOP generation, compliance, and biosimilarity demonstration. She also has extensive experience in authoring and performing expert reviews of the Pharmaceutical Quality/CMC sections (Module 3) of the eCTD for regulatory submissions.
Before COUR and BioTechLogic, Ashley was a Research Chemist in the Office of Testing and Research at the US FDA. While with the agency, she served as an expert in analytical method development, qualification, and validation, specializing in mass spectrometry, chromatography, and spectroscopy. She has authored 20 peer-reviewed publications. Prior to joining FDA, Ashley was a Chateaubriand Fellow of the Office of Science of Technology of the Embassy of France in the United States at École Polytechnique in Palaiseau, France. She has a BA in Chemistry from Pomona College in Claremont, California, and a PhD in Chemistry from the University of Arizona. She has also taken post-graduate courses at Arizona State University, with a focus on statistics for biological systems.
Cour Pharmaceuticals Development Company
Vice President of Operations and Quality
Director of Quality
US Food and Drug Administration, CDER, Division of Pharmaceutical Analysis
Research Chemist
Chemist
ORISE Fellow
University of Arizona
PhD in Chemistry (Analytical)
Pomona College
BS in Chemistry