Assistant Manager, Analytical Method Development

Role Overview: You will be responsible for developing, optimizing, and validating analytical methods using GC and GC-MS/MS for various sample matrices. Your role will involve performing routine and non-routine analysis of raw materials, intermediates, and finished products. You will interpret complex chromatographic data, ensuring accurate documentation and reporting. Additionally, you will maintain and calibrate GC and GC-MS/MS instruments to ensure compliance with regulatory standards. Troubleshooting instrument and method-related issues to ensure uninterrupted lab operations will also be a part of your responsibilities. You will be preparing SOPs, method validation protocols, and reports in accordance with regulatory guidelines and collaborating with cross-functional teams including R&D, QA/QC, and regulatory affairs. Adherence to GLP/GMP standards and maintaining laboratory safety and compliance will be essential. 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. - 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. Qualifications Required: - 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. About the Company: Amneal is an equal opportunity employer that values diversity and inclusion. They do not discriminate based on caste, religion, gender, disability, or any other legally protected status. Amneal fosters a workplace where all individuals are respected and provided with equal opportunities. (Note: Additional details about the Human Resources team and their key roles have been omitted as per your request.),