Extractables & Leachables Fellow

The Extractables & Leachables Testing department evaluates container closure systems, delivery systems, manufacturing components, and medical devices for extractable and leachable compounds. This process involves exposing the materials to extraction solvents and then testing the resulting extraction solutions by a variety of analytical techniques. These screening methods require extensive data interpretation in order to identify the compounds using proprietary databases. Team members will perform worst case extractions on various materials and then test the resulting extraction solutions. The team will test drug product stored in the container closure system to determine compounds leaching out of the materials and into the drug product. Team members will establish method conditions that meet the intention of the analytical method and then perform a series of tests to ensure the method is appropriate for its given function. Team members will perform investigative testing to identify unknown compounds relying on mass spectrometers. Applies GMP/GLP in all areas, demonstrates client service skills, teamwork, and collaboration. Performs laboratory operations with high accuracy. Performs preparations of reagents, samples, and standards, documents testing, observations, deviations, and results. Performs routine, non-routine and complex analyses including calibration and troubleshooting of instruments independently. Guides junior staff, does independent research, presents research finds at industry conferences, be a technical resource, provides support for corporate initiatives, provides coverage for management when needed. Understands calculations and utilizes computers for information access and report preparation. Suggest and implement lab improvements and conducts all activities in a safe and efficient manner.