Bioanalytical Process Development


THE KEYWORDS

process development, analytical chemistry, protein therapeutics, oncolytic viruses


THE ESSENCE OF WHAT I DID

I performed, developed, qualified, and verified analytical assays for biologics (BiTEs, mAbs, bsAbs, fusion proteins, and oncolytic viruses) in clinical trials to be transferred into quality control and commercial PD environments, wrote, edited, and reviewed technical documents, and collaborated with junior and senior-level scientists and project managers. (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 developed these assays to ensure they’re accurate and robust enough to provide reliable results to those teams every time.  We also transferred our methods to quality control or commercial advancement to ensure Amgen used the best methods we had at any given point.  As an Associate, I developed, verified, and qualified chromatographic (SEC, CEX), electrophoretic (CE-SDS), and spectroscopic (VPE, FPE) methods.  I performed data and statistical analyses on my results and drafted technical documents that were used throughout Amgen.  Further, I acted as an SME on my methods, interacted with routine testing and QC, and reviewed technical documents.