Potency Assay Scientist

We are seeking a highly skilled and motivated individual with in-depth knowledge of cell-based and potency assays and comfortable with troubleshooting. The Scientist will serve as SME for mRNA and gRNA potency assays to support several client programs. Primary Responsibilities:Optimize, technical transfer, qualification, and validation of potency assays used for lot release and characterization of cell and gene therapy products and critical materials.Acting as an SME resource for potency assays.Execution of complex GMP release and stability assays such as cell based functional assays, flow cytometry methods, ddPCR, ELISA, and NGS assays.Author and review SOPs and technical reports.Work with cross-functional groups within the client environment to participate in various aspects of method development, transfer, process and product characterization, comparability, and investigations.Analyze, track, and trend data to monitor analytical assays and ensure consistency in assay performance.