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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: 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). Operate and maintain Agilent instrumentation, including system calibration, maintenance, and basic troubleshooting. Use Agilent MassHunter software for data acquisition, processing, and reporting of LC-MS and GC-MS results. Conduct method validation as per ICH Q2 (R1) guidelines, and prepare protocols and reports accordingly. Perform risk-based impurity profiling for Nitrosamines based on synthetic pathway, excipient reactivity, and formulation interactions. Execute forced degradation studies and assess potential nitrosamine formation under stress conditions. Prepare and maintain technical documentation such as method development reports, SOPs, validation protocols/reports, and regulatory submission content. Ensure compliance with GMP, GLP, and data integrity standards (ALCOA) throughout all analytical activities. Support regulatory audits and inspections by providing method details and data summaries related to nitrosamine testing. Collaborate with cross-functional teams including QA, Regulatory Affairs, and Formulation Development. Qualifications: M.Sc. / B.Pharm / M.Pharm in Analytical Chemistry, Pharmaceutical Chemistry, or related discipline. 25 years of hands-on experience in method development using Agilent LC-MS and GC-MS, with a focus on Nitrosamine impurities. Proficiency in Agilent MassHunter software (Qual, Quant, Optimizer) and OpenLab. Sound knowledge of Nitrosamine risk assessment, ICH M7, and current regulatory guidance. Preferred Skills: Experience with software like MassHunter and OpenLab . Familiarity with structural elucidation using MS/MS fragmentation. Knowledge of ICH M7 (R1) , genotoxic impurities (GTIs) , and carcinogenic risk assessment . Experience with sample preparation techniques (e.g., derivatization, headspace analysis). Familiarity with LOD/LOQ requirements for Nitrosamines (ppb level sensitivity). Understanding of mass fragmentation patterns, ion source tuning, and matrix effect management. Soft Skills: Strong analytical and problem-solving mindset. Good communication and report-writing skills. Ability to work independently and manage priorities effectively. Team player with a proactive approach to learning and continuous improvement. Experience Level: Mid-Level55b20050-bc17-4e5d-bfce-3c406318dffc