Assistant Director
Current- Responsible for conducting quality control testing of in-process samples, drug substances and drug products according to GMP SOPs for multiple projects simultaneously.- Project team lead responsible for tox support, release and stability testing of multiple development compounds.- Main analyst responsible for managing stability programs for commercial drug substances and products.- Leads communication and coordination with CRO; organizes meetings, testing, troubleshooting, training, finances and annual project reviews.- Presents and participates in internal and external scientific meetings.- Coordinates with multiple internal departments and external organizations to plan studies, perform testing, and troubleshoot analytical issues.- Trained multiple analysts on main analytical techniques as well as providing training sessions for multiple external labs.- Conducted analytical method validations, forced degradation studies, instrument troubleshooting and unexpected analytical result investigations.- Revised, developed, and updated SOPs as required.- Authors scientific reports and portions of Chemistry, Manufacturing, and Controls (CMC) section of regulatory filings.