Department: Analytical Research & Development / Quality Control
Position: Scientist / Senior Scientist – Trace Level Analysis
Location: Hyderabad
Experience: 4 to 9 years
Employment Type: Full time
Job Summary
We are looking for an experienced Scientist/Senior Scientist with strong expertise in trace-level quantification of Genotoxic Impurities (GTIs), Nitrosamines, NDSRIs, and Nitrites in Drug Substance (DS) and Drug Product (DP). The candidate should have hands-on experience with LC-MS/MS, HRMS and other mass spectrometry-based analytical techniques for qualitative and quantitative analysis.
Key Responsibilities
Perform trace-level analysis and quantification of GTIs, Nitrosamines, NDSRIs and Nitrites in DS and DP.
Develop, optimize and validate analytical methods for nitrosamine and genotoxic impurity analysis.
Perform qualitative and quantitative analysis using:
LC-MS/MS
HRMS / High-Resolution Mass Spectrometry
Other advanced MS-based analytical techniques.
Conduct method development, method optimization,
validation and verification as per applicable regulatory requirements.
Handle sample preparation and extraction techniques suitable for ultra-trace level impurity analysis.
Evaluate analytical data, identify unknown impurities and perform structural elucidation where required.
Troubleshoot analytical methods, instrument-related issues and unexpected results.
Maintain complete and accurate analytical documentation, raw data and reports.
Interpret mass spectra and chromatographic data and prepare technical reports.
Support investigations related to OOS/OOT, atypical results and analytical discrepancies.
Stay updated with evolving regulatory expectations and guidelines related to Nitrosamines, NDSRIs and GTIs.
Work closely with Analytical R&D;, QC, QA, Regulatory Affairs and other cross-functional teams.
Required Qualifications & Experience
M.Sc./M.Pharm./M.Tech./Ph.D. in Analytical Chemistry, Pharmaceutical Chemistry, Chemistry or a related discipline.
Relevant ex