Amy Kimbro
About Amy Kimbro
Amy Kimbro serves as the Director at AustinPx, Pharmaceutics and Manufacturing, where she has worked since 2022. With two decades of experience in the pharmaceutical industry, she specializes in quality assurance and regulatory affairs, holding an MSc from Temple University and a BA from Texas A&M University.
Current Role at AustinPx
Amy Kimbro currently serves as the Director at AustinPx, Pharmaceutics and Manufacturing, a position she has held since 2022. In this role, she oversees various quality assurance initiatives and ensures compliance with industry standards. Her leadership is pivotal in maintaining the quality of products and processes within the organization. Prior to her current role, she was the Associate Director of Quality Assurance at the same company, where she contributed to enhancing quality systems and regulatory compliance.
Previous Experience in Quality Assurance
Amy Kimbro has extensive experience in quality assurance within the pharmaceutical industry. She worked at AustinPx as a QA Manager from 2016 to 2021, where she managed quality control processes and compliance with FDA regulations. Her career began at Allergan as a Laboratory Technician, and she later served as an Analyst II at Alkermes. This trajectory has provided her with a comprehensive understanding of quality systems from clinical to commercial stages, including regulatory submissions.
Educational Background
Amy Kimbro holds a Master of Science in Regulatory Affairs and Quality Assurance from Temple University, which she completed between 2018 and 2020. She also earned a Bachelor of Arts in Chemistry with a minor in English from Texas A&M University, studying there from 1999 to 2003. Her educational background supports her expertise in quality assurance and regulatory compliance within the pharmaceutical sector.
Specialized Expertise in Pharmaceutical Quality
Amy Kimbro possesses specialized expertise in clinical trials for small molecules and has a strong background in risk-based quality systems. Her experience includes vendor management and compliance with FDA regulations. She is knowledgeable in handling DEA controlled substances and has experience filing IND/CTA applications. Her work spans various dosage forms, including solutions, suspensions, gels, and solid oral products.
Career Timeline in the Pharmaceutical Industry
Amy Kimbro has two decades of experience in the pharmaceutical industry, focusing on quality and regulatory aspects. She began her career at Allergan and has since worked at several companies, including PharmaForm and Elan Corporation. Her roles have evolved from laboratory technician to analyst, and ultimately to director, reflecting her growth and expertise in quality assurance and regulatory affairs.