At Amgen, I develop, validate, and transfer analytical methods supporting the characterization and release of raw materials, process-related impurities, and formulation excipients used in protein therapeutic drug products.
My work spans process development from First in Human clinical trials through commercialization, marketing applications, and post-approval. I’m a subject matter expert in HPLC and LC-MS, with a focus on ICH guidelines, compendia methods, and cGMP.
At Amgen, I developed an LC-MS method to quantify free fatty acids and monitor polysorbate degradation in protein-containing formulations. I also develop and troubleshoot methods using liquid chromatography with UV, RI, and MS detectors.
Earlier, at the University of Minnesota, I developed and validated a targeted mass spectrometry assay for apolipoproteins in plasma lipoproteins. My research has also included automated enzyme-inhibition screening and online chromatography platforms, with published articles and a patent.
