SENIOR SCIENTIST

Department Details

Role Summary

1. Development of analytical methods using LC-MS for Large molecules (peptides and oligonucleotides), data processing, interpretation and report preparations.
2. Experience required on method validations/qualification as per ICH guidelines.
2. Experience on calibration & qualification of characterization instruments.
3. Good hands-on instruments and data interpretation of characterization instruments and methods (, DLS, GPC, LC-MS, FT-IR, CD, SEC-MALS, Fluorescence plate reader etc.,)
4. Drafting and/or review of sameness-characterization reports of drug substance and drug product.
5. To transfer the analytical technology and characterization methods to the manufacturing sites or CTL for regular release testing at manufacturing site internal/external.
plan timely analysis of samples, compiling and tracking the comparative results.

Key Responsibilities