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:
* 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.
* 2–5 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-Level