Manager, Extractables and Leachables Testing, Eurofins Lancaster Laboratories

>> My name is Jennifer Martell Roark and I am currently the manager of the Extractables Leachables Testing group at Eurofins Lancaster Laboratories. So what basically that means is we do testing of container closure systems, which is packaging, and also the components that go into bioprocessing systems for biologics to make sure that none of the plastics are leeching any chemicals that might be toxic or might affect the drug products when they touch the different components. So we use a variety of different techniques. First of all, we start with an extraction and so we use different solvents that would extract different types of compounds and then once we generate those extracts we test them by gas chromatography and liquid chromatography using mass spectrometry to detect the compounds and identify them. So for me, currently, since I'm a manager I make sure that all the processes occur. I make sure that all the group leaders are servicing our clients, designing experiments correctly. We work together with our clients and come up with quotations for the work that we're doing for study designs. We come up with timelines. We offer consultation services if we need to. We make sure that all the analysts have their schedules for the day and week and sometimes even the month depending on how long a project will take us to do. I also have to make sure that all of our instrumentation is satisfactorily up and running and all the instrumentation meets GMP requirements and I also make sure that we have enough instrumentation and lab space to be able to do the testing.