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 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.
Educational Qualification
M.SC./ in Biochemistry / Life Sciences / Biotechnology.
Technical/functional Skills
Sound knowledge of analytical method development, qualification and structural and functional characterization of therapeutic proteins.
Experience of biosimilarity assessment of biologics for regulated market is desirable.
Experience of analytical development for monoclonal antibodies and peptide is highly desirable.
