Scientist Ii
CurrentProduct Development-Design and oversee Research use only (RUO), Analyte Specific Reagent (ASR) and in vitro diagnostic (IVD) antibody reagents from design planning, experimental testing, documentation drafting to product release.-Design and manage the development of non-antibody IVD reagent from design planning, experimental testing, documentation drafting to product release.-Design and execute troubleshooting experiments for released and on-going RUO and ASR products.-Ensure the product development process and documentation are documented in accordance with ISO 13485:2016, FDA regulation and GMP.-Communicate within and between Product development, QA, QC, Marketing, and Manufacture departments for product development, troubleshooting, internal validation and release.-Mentor, train, and provide scientific guidance to the Research Associates in the team.