MANAGER - 2 - Sun Pharmaceutical Industries : Job Details

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Company: Sun Pharmaceutical Industries Ltd

• 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 techniques with emphasis on LC-MS, CEX-MS, SEC-MS characterization of innovator product batches sourced from different geographical regions and preparation of quality target profiles.
• Responsible for designing advanced 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 the analytical laboratory in compliance with GLP regulations.
• The candidate is responsible for the operation and maintenance of the MS instruments.
• Manage chemicals, consumables, and critical reagents inventory. Perform calibration of instruments and equipment. Troubleshoot instrument performance and equipment issues.
• Responsible for managing regulatory queries.
• The candidate is expected to draft technical content for regulatory dossiers.