Ashley Gucinski, Ph.D.

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.

• Provide expert analytical advice and support for structural elucidation and characterization studies, release and stability test method development, qualification, validation, and method transfer.
• Author or perform expert review of regulatory documents, including briefing books, INDs, IMPDS, NDAs, ANDAs, BLAs, and MAAs (eCTD Module 2 and 3).
• Provide expert advice related to the establishment of analytical methods, specifications and their justifications, including statistical approaches, for release testing, stability testing, and comparability evaluation.
• Provide expert consulting and remediation related to laboratory controls, including reference standard programs, sample management, method validation, critical reagents, and data integrity.
• Perform quality audits in with respect to GLP and GMP compliance of contract research, testing, and manufacturing facilities.
• Assist with management of and/or manage third party testing locations on behalf of clients. *Advise on approaches for establishing analytical biosimilarity using the 351(k) pathway for biosimilars, including the use of appropriate statistical tools.

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