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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.