Scientist
CurrentResponsible for quality control testing of process removal and final API batch release samples with multiple technologies. Maintains of mammalian cell lines. Reviews and approves analytical testing documents including for batch release samples. Performs analytical investigation and deviation investigation in accordance with 21CFR211.100. Supports priority testing outside of normal business hours and 24/7 temperature monitoring. Leads team morning huddle meeting. Authoring of global methods including multiple ELISA and qPCR methods for API. Review local methods up for periodic review against other local methods, global methods, regulatory registration, and validation documents. Leads continuous improvement efforts.