Analytical Scientist
4 weeks ago
- Development of anlaytical methods using LC-HRMS for Large moelcules, data prcoessing, intrepretation and report preparations; Experince required on method validations as per ICH guidlines.
- Review and support for all analytical activities required for product development at Research and Development lab (R&D) and/or Contract Research Organization (CRO), CTL.
- Good hands on instruments and data interpretation of characterization methods ((eg., In-vitro release test, reverse engineering, and characterization-based techniques (eg., PSD, NMR, GPC, LC-MS, FT-IR, PXRD, TEM, SEM, CD, SEC-MALS, Fluorescence plate readtes etc.,)
- Drafting and/or Review of Sameness-Characterization reports of drug substance and drug product.
- To transfer the analytical technology and characterization methods to the manufacturing sites or CTL for regular release testing at manufacturing site internal/external.
- To plan timely analysis of samples, compiling and tracking the comparative results.
Qualification & Experience:
- Ph.D/M.Pharm/M.Sc.
- 5-10 years of experience
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