Department Details

Role Summary

1. Development of characterization analytical methods of peptides and oligonucleotides using HPLC, UPLCs, DLS, SEC-UV-MALS, FTIR, CD, GPC etc.
2. Processing, interpretation and report preparations.
3. Experience required on method validations/qualification as per ICH guidelines.
4. Experience on calibration & qualification of characterization instruments.
5. Drafting and/or review of sameness-characterization reports of drug substance and drug product.
6. To transfer the analytical technology and characterization methods to the manufacturing sites or CTL for regular release testing at manufacturing site internal/external.
7.To plan timely analysis of samples, compiling and tracking the comparative results.

Key Responsibilities

• To developed analytical methods, data processing, interpretation of the data, preparation and review of reports of complex products (peptides and oligonucleotides).

Educational Qualifications

Required Education Qualification: M.Sc
Required Experience: 2 - 5 years