Assistant Manager, Analytical Method Development | GC-MS | OSD

Key Responsibilities:

• Develop, optimize, and validate analytical methods using GC and GC-MS/MS for various sample matrices.
• Perform routine and non-routine analysis of raw materials, intermediates, and finished products.
• Interpret complex chromatographic data and ensure accurate documentation and reporting.
• Maintain and calibrate GC and GC-MS/MS instruments, ensuring compliance with regulatory standards.
• Troubleshoot instrument and method-related issues to ensure uninterrupted lab operations.
• Prepare SOPs, method validation protocols, and reports in accordance with regulatory guidelines (e.g., ICH, FDA, EMA).
• Collaborate with cross-functional teams including R&D, QA/QC, and regulatory affairs.
• Ensure adherence to GLP/GMP standards and maintain laboratory safety and compliance.

Skills Required:

• Experience in trace-level analysis and impurity profiling.
• Knowledge of derivatization techniques and thermal desorption methods.
• Exposure to regulatory audits and compliance documentation.

Qualifications & Experience:

• M.Sc. / M. Pharm / Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related field.
• Minimum 5-6 years of hands-on experience in GC and GC-MS/MS method development and analysis.
• Strong understanding of chromatographic principles, mass spectrometry, and sample preparation techniques.
• Experience with software platforms such as ChemStation, MassHunter, or equivalent.
• Familiarity with regulatory requirements and documentation practices.