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 experience in trace-level quantification of GTIs, Nitrosamines and Nitrites in DS and DP.
- Hands-on experience in Nitrosamine analysis , with prior experience in NDSRIs preferred.
- Strong practical expertise in LC-MS/MS and HRMS .
- Experience in qualitative and quantitative analysis using advanced mass spectrometry-based techniques .
- Good understanding of method development, validation and troubleshooting .
- Knowledge of analytical requirements and regulatory expectations for genotoxic impurities and nitrosamines .
- Robust data interpretation, documentation and problem-solving skills.

Preferred Skills
- Experience with NDSRI method development and validation .
- Exposure to high-resolution MS techniques and accurate-mass measurements.
- Knowledge of trace-level analytical challenges such as matrix effects, carryover, sensitivity and selectivity .
- Experience working in a GMP-regulated pharmaceutical environment .
- Good understanding of regulatory guidelines related to nitrosamines and GTIs.

Key Competencies
- Analytical problem-solving
- Mass spectrometry expertise
- Method development & validation
- Attention to detail
- Data interpretation
- Regulatory compliance
- Cross-functional collaboration

Preferred Candidate: Candidates with strong hands-on experience in Nitrosamine/NDSRI analysis using LC-MS/MS and HRMS will be given preference.

📌 Scientist / Senior Scientist – Trace Level Analysis (Hyderabad)
🏢 Ritsa Pharma
📍 Hyderabad