Executive Job at Amneal Pharmaceuticals | MSc Analytical Chemistry Graduates Apply Now
Amneal Pharmaceuticals is seeking an Executive – Method Development (Extractable & Leachable | OSD) in Ahmedabad, Gujarat. This role is ideal for experienced analytical professionals with expertise in HPLC, LC-MS, GC-MS, and ICP-MS techniques, aiming to contribute to cutting-edge extractables and leachables (E&L) studies that ensure drug product quality and compliance. Join a global pharmaceutical leader committed to innovation, diversity, and healthcare advancement.
- Job Position: Executive – Method Development (Extractable & Leachable | OSD)
- Location: Ahmedabad City, Gujarat, India
- Job ID: 6557
About the Company
Amneal Pharmaceuticals is a trusted global pharmaceutical company dedicated to providing affordable, high-quality medicines. With a strong commitment to innovation, Amneal develops and manufactures a diverse range of pharmaceutical products. The company fosters a workplace that values diversity, inclusion, and equal opportunity, empowering employees to drive meaningful impact in healthcare worldwide.
Job Description
As an Executive – Method Development (Extractable & Leachable | OSD), you will be responsible for conducting analytical studies, developing and validating methods, and ensuring compliance with regulatory guidelines for E&L testing. This role requires expertise in advanced analytical techniques and collaboration with cross-functional teams to deliver high-quality results for
regulatory submissions and product safety.Key Responsibilities for Executive Job at Amneal Pharmaceuticals
- Conduct extractables and leachables studies on packaging components, medical devices, and drug products.
- Perform sample preparation, extraction, and analysis using HPLC, GC-MS, LC-MS, ICP-MS, ICP-OES, and related instruments.
- Develop and validate analytical methods for E&L testing in line with regulatory guidelines (USP <1663>, <1664>).
- Interpret, quantify, and report analytical data, including unknown compounds.
- Prepare technical reports, protocols, and documentation for regulatory submissions.
- Maintain, calibrate, and troubleshoot analytical instruments.
- Collaborate with cross-functional teams including formulation, regulatory affairs, and quality assurance.
- Ensure compliance with GLP/GMP standards and laboratory safety protocols.
Qualifications for Executive Job at Amneal Pharmaceuticals
- M.Sc., M. Pharm, or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
- 3–5 years of experience in extractables and leachables testing.
- Proficiency in HPLC, GC-MS, LC-MS, ICP-MS, ICP-OES, and related techniques.
- Strong understanding of regulatory requirements for E&L studies.
- Proven experience in method development, validation, and troubleshooting.
- Excellent documentation, interpretation, and communication skills.
- Desirable: Knowledge of polymer chemistry, material characterization, and toxicological risk assessment.
Benefits of Joining Amneal
- Be part of a global pharmaceutical leader with a strong reputation in innovation.
- Opportunities to work with advanced analytical technologies.
- Collaborative, diverse, and inclusive work culture.
- Exposure to global regulatory requirements and industry best practices.
- Strong career growth and learning opportunities in analytical R&D.
