Work as Method Development Executive at Amneal Pharma

Amneal Pharmaceuticals, Inc. is a global pharmaceutical company. Our development, manufacturing, and distribution of a diverse portfolio of 270+ high-quality medicines, team of 7,500+ colleagues helps make healthy possible through.

Post : Executive, Method Development - Extractable & Leachable | OSD

Job Description
• 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 (e.g., USP <1663>, <1664>).
• 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.
• Experience with polymer chemistry and material characterization.
• Familiarity with toxicological risk assessment and safety thresholds, if possible

Candidate Profile
• 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.

Additional Information
Experience : 3-5 years
Qualification : M.Sc. / M. Pharm / Ph.D
Location : Ahmedabad City, Gujarat
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Extractable & Leachable | OSD
End Date : 31st October 2025