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

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.
  

About Us

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.

About The Team

The

Human Resources team

partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key Roles That The Human Resources Team Performs

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.