FCA
Newark, DE
Senior Research Associate (FCA)
Develop, validate, transfer & execute quantitative flow cytometrybased bioanalytical methods in a GLP-compliant CRO lab. Perform analysis of cellular targets, biologics & endogenous biomarkers in human & nonclinical biological matrices using flow cytometry & related immunochemical & molecular techniques. Execute regulated bioanalytical workflows from sample receipt through data generation & reporting. Conduct cytometric data analysis, data reduction, statistical evaluation & quality control review in accordance w/ established procedures. Prepare GLP-compliant study doc., incl. reports, deviations, investigations & CAPA records. Maintain lab. compliance w/ GLP, GCP 7 GDP requirements. Perform routine cytometry instrument setup, calibration, maintenance & performance monitoring. Support audit & inspection activities & provide tech. guidance to lab. staff as assigned. Req: MS in Biology, Biochemistry, Molecular...