Key Responsibilities: 

The candidate is expected to develop LC-MS based methods for protein and peptide product characterization. The candidate is expected to qualify the methods for intended purpose for all pipeline products. The candidate is expected to design and implement integrated strategies, linking appropriate chromatography and mass spectrometry tools, to perform a qualitative and quantitative assessment of product related variants and impurities. Develop and apply novel sample preparation with emphasis on LC-MS, CEX-MS, SEC-MS Characterization of innovator product batches sourced from different geographical region and preparation of quality target profile. Responsible for designing advance workflows such as multi-attribute methods for PTMs, sequence variants, qualitative and quantitative profiling of HCPs, Disulfide shuffling and bond analysis, cell culture metabolite analysis, glycan analysis etc. Preparation and review of method development reports (MDR) and analytical test procedures (ATP). Responsible for operating and maintaining analytical laboratory in compliance with GLP regulations. The candidate is responsible for the operation and maintenance of the MS instruments To manage chemicals, consumables & critical reagents inventory. Performs calibration of instruments and equipment. Troubleshoots instrument performance and equipment issues. Responsible for managing the regulatory queries. The candidate is expected to draft the technical content for regulatory dossier.