Title:  MANAGER - 2

Key Responsibilities: 

• The candidate is expected to develop Surface Plasmon Resonance (SPR) based methods to measure the kinetic and equilibrium binding constants for protein and peptide products.


• Responsible for analytical method qualification for all pipeline products.
• Characterization of innovator product batches sourced from different geographical region and preparation of quality target profile.
• Analytical similarity assessment of in-house products.
• 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 SPR 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.