Aimee Weber Email & Phone Number

I am a team oriented, goal driven individual, with demonstrated leadership ability. Having worked in the pharmaceutical industry as an analytical chemist and CMC regulatory scientist with over 20 years of experience in research and development, I have supported the development of both drug substance and drug product. My experiences have included but are not limited to: Leading technical transfer teams, Activities to support batch manufacture and release, Authoring of necessary documentation for clinical and safety assessment studies , Authoring protocols for and performing analysis of stability studies and determining shelf life, Authoring regulatory submissions, and method development and validation. I have overseen the work of third party contract organizations, including reviewing data packages and authoring technical agreements. As a consultant, I have supported the CMC regulatory activities for small molecules, large molecules, tissue products, biologics, and combination products. I have been involved with the authoring of Modules 2.3 and 3 in support of US FDA filings, authored IMPD-Q dossiers for EMA, supported CMC information within meeting packages for health authority interactions.Additionally, I have had the opportunity to manage a team of bench level scientists and been responsible for prioritizing and assigning work as well as reviewing experimental documentation. I have represented my local site on global teams and have been responsible for the training and implementation of new software packages.

Listed skills include Analytical Chemistry, Hplc, Drug Development, Chromatography, and 18 others.