Executive – Method Development (Extractables & Leachables | OSD)
Location: Ahmedabad City, Gujarat, India
Job ID: 6557
Posting Date: 23/09/2025
Application Deadline: 04/10/2025
Job Category: Analytical R&D
Job Schedule: Full-time
Degree Level: Master’s Degree (M.Sc./M.Pharm/Ph.D.)
Company Overview
Amneal Pharmaceuticals is an equal opportunity employer committed to diversity and inclusion. We foster a workplace that values innovation, collaboration, and compliance with regulatory standards.
Job Summary
The Executive – Method Development (E&L) is responsible for conducting extractables and leachables studies on packaging components, medical devices, and drug products. This role involves analytical method development, validation, and reporting in compliance with regulatory guidelines.
Key Responsibilities
Conduct extractables & leachables studies on packaging materials, devices, and drug products
Perform sample preparation, extraction, and analysis using:
HPLC
GC-MS
LC-MS
ICP-MS
ICP-OES
Other relevant analytical instruments
Develop and validate analytical methods in compliance with USP <1663>, <1664> and other 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, ensuring calibration and preventive maintenance schedules are followed
Collaborate with cross-functional teams including Formulation, Regulatory Affairs, and Quality Assurance
Ensure GLP/GMP compliance and laboratory safety standards
Additional Skills / Desired Knowledge
Experience with polymer chemistry and material characterization
Familiarity with toxicological risk assessment and safety thresholds
Qualifications & Experience
Educational Qualification: M.Sc., M.Pharm, or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related field
Experience: 3–5 years in extractables and leachables testing
Technical Skills:
Proficiency in HPLC, GC-MS, LC-MS, ICP-MS, ICP-OES
Strong understanding of regulatory requirements for E&L studies
Experience in method development, validation, and troubleshooting
Excellent documentation, data interpretation, and communication skills
About the Team
Human Resources Team Roles:
Executive Role: Strategic input in all aspects of people management
Audit Role: Ensure compliance with legal and best-practice employment policies
Facilitator Role: Support all departments in achieving objectives via effective employment practices (Talent Acquisition, Learning & Development, Reward Systems, Performance Management, Health & Wellbeing)
Consultancy Role: Provide expert advice on workforce management, employee relations, and performance
Service Role: Equip the organization to respond to developments in employment law and labor market trends
Application
Apply online before 04/10/2025, 04:36 PM
Location: Plot No. 15,16,17, Pharmez Special Economic Zone (SEZ), Ahmedabad, GJ, 382110, India
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