Executive, Method Development - Extractable & Leachable | OSD

Role Overview: As a member of the team, you will be responsible for conducting extractables and leachable studies on packaging components, medical devices, and drug products. Your role will involve performing sample preparation, extraction, and analysis using techniques such as HPLC, GC-MS, LC-MS, ICP MS, ICP OES, and other relevant instrumentation. You will also be developing and validating analytical methods for E&L testing in compliance with regulatory guidelines. Additionally, you will interpret and report analytical data, prepare technical reports, protocols, and documentation for regulatory submissions, and collaborate with cross-functional teams. Key Responsibilities: - Conduct extractables and leachable studies on packaging components, medical devices, and drug products. - Perform sample preparation, extraction, and analysis using techniques such as HPLC, GC-MS, LC-MS, ICP MS, ICP OES, and other relevant instrumentation. - Develop and validate analytical methods for E&L testing in compliance with regulatory guidelines. - Interpret and report analytical data, including identification and quantification of unknown compounds. - Prepare technical reports, protocols, and documentation for regulatory submissions. - Maintain laboratory instruments and ensure calibration and preventive maintenance schedules are followed. - Collaborate with cross-functional teams including formulation, regulatory affairs, and quality assurance. - Ensure compliance with GLP/GMP standards and laboratory safety protocols. Qualification Required: - M.Sc. / M. Pharm / Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related field. - 3-5 years of experience in extractables and leachable testing. - Proficiency in HPLC, GC-MS, LC-MS, ICP MS, ICP OES, and other analytical techniques. - Strong understanding of regulatory requirements for E&L studies. - Experience in method development, validation, and troubleshooting. - Excellent documentation, data interpretation, and communication skills. About Us: Amneal is an equal opportunity employer that values diversity and inclusion, promoting a workplace free from discrimination based on caste, religion, gender, disability, or any other legally protected status. (Note: The section "About The Team" has been omitted as per the instructions provided.),