Job Description

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.

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.