Development & Qualification of multiplex based cytokine release assay and Elispot/ flow cytometry based T cell assays to measure the innate and adaptive Immunogenicity of synthetic peptide products

Job Responsibilities:

Manage the study sample analysis for pipeline products, preparation of study schedule, design of experiments, trouble shooting, data analysis and review of reports. Isolation of PBMC from whole blood and maintenance of commercial cell lines. Coordinate with internal and external stakeholders for reagent procurement, blood collection, instrument installation and calibration. Statistical analysis of data using software. Preparation/ review of standard operating procedures (SOP), method development reports (MDR), sample analysis report (SAR) and analytical test procedures (ATP). Responsible for operating and maintaining analytical laboratory in compliance with GLP regulations. Responsible for the operation and maintenance of the Flow Cytometry, Multiplex, ELISPOT and other instruments and statistical software. Managing of chemicals, consumables & critical reagents inventory. Performing calibration of instruments and equipment. Troubleshooting instrument performance and equipment issues. Draft responses for regulatory queries and facilitate internal and external audits.