At Bristol Myers Squibb, I build data trending analyses on QC laboratory results for commercial Cell Therapy drug product and produce quarterly reports used by regulatory and quality stakeholders. I also prepare FDA-facing analytics packages and develop procedures that document QC data handling.
At Takeda Pharmaceuticals, I supported QC lab data systems including MODA, Waters HPLC, and NucleoView, and executed tier 2 projects for 21 CFR Part 11 compliant systems across four MaBioOps sites. My background also includes systems administration, network infrastructure, laboratory instrumentation, and QC work in regulated pharmaceutical environments.
