Bioanalytical Process Development

THE KEYWORDS

process development, analytical chemistry, clinical trials


THE ESSENCE OF WHAT I DO

I perform, develop, qualify, and verify analytical assays for biologics (BiTEs, mAbs, bsAbs, fusion proteins) in clinical trials to be transferred into quality control and commercial PD environments, write, edit, and review technical documents, and collaborate with junior and senior-level scientists. (2019-present)


THE BACKGROUND

Pivotal Attribute Sciences, Amgen

During development, upstream and downstream teams use bioanalytical testing to elucidate important characteristics in drug candidates.  Measuring aggregation, surface charge variations, and fragmentation patterns allow scientists to understand how these molecules behave under stress conditions (like light or pH) or throughout the purification process (before vs. after a certain filtration step).

My team develops these assays to ensure they’re accurate and robust enough to provide reliable results to those teams every time.  We also transfer our methods to quality control or commercial advancement to ensure Amgen is using the best methods we have at any given point.  As an Associate, I develop, verify, and qualify chromatographic (SEC, CEX), electrophoretic (CE-SDS), and spectroscopic (VPE, FPE) methods.  I perform data and statistical analyses on my results and draft technical documents that are used throughout Amgen.  Further, I act as an SME on my methods, interact with routine testing and QC, and review technical documents.