Scientist Ii
Current• Leads a team of three in full validation of cell-based neutralizing antibody assay• Writes validation plans, sample analysis plans, methods, and worksheets for GCP/GCLP and GLP studies• Creates schedule for cell maintenance of three human cell lines used in six immunoassays• Plans qualification and validation experiments for cell-based neutralizing antibody, pharmacokinetic, and toxicokinetic assays.• Compiles data from in-study cut point, qualification, and validation experiments into summary tables in excel for presentation to client.• Drafts reports for sample analysis, validation, and critical reagent bridging• Organizes and maintains study binders in hard copy and digital formats for GCP/GCLP and GLP studies• Generates protocols in Gen5 and LIMS for data analysis