Session – Development and Transfer of Analytical Assays for Polysorbate Excipients in your Drug Product I have lead Analytical Development activities at Promedior since 2013.  Responsibilities include person-in-plant activities for manufacturing, QC release of drug substance/product, overseeing project management for drug development, writing/maintaining sections of CMC submissions to Agencies; developing, validating, troubleshooting assays and managing testing; maintaining release and stability programs at contract laboratories; conducting experiments to evaluate critical quality attributes; and developing new/improved formulations for the drug.  In 2012, I was the Laboratory Director at Blue Stream Laboratories.  From 1999 – 2011, I worked at Stryker Biotech, first as a Scientist and from 2005 as Head of Analytical Development