Job Description
Job Summary:
We are looking for a highly motivated and skilled Analytical Method Development Analyst with hands-on experience in Agilent LC-MS and GC-MS systems, focusing on the development and validation of methods for Nitrosamine impurities in pharmaceutical substances and products. The candidate should have a strong understanding of regulatory expectations, impurity profiling, and analytical troubleshooting in a GMP-compliant environment.
Key Responsibilities:
1. Develop, optimize, and validate analytical methods for the detection and quantification of Nitrosamine impurities using Agilent LC-MS/MS and Agilent GC-MS/MS systems (Triple Quadrupole or QTOF).
2. Operate and maintain Agilent instrumentation, including system calibration, maintenance, and basic troubleshooting.
3. Use Agilent MassHunter software for data acquisition, processing, and reporting of LC-MS and GC-MS results.
4. Conduct method validation as per ICH Q2 (R1) guidelines, and prepare protocols and reports accordingly.
5. Perform risk-based impurity profiling for Nitrosamines based on synthetic pathway, excipient reactivity, and formulation interactions.
6. Execute forced degradation studies and assess potential nitrosamine formation under stress conditions.
7. Prepare and maintain technical documen...