Key Responsibilities:

- Lead API characterization activities using advanced analytical techniques such as LC-MS, GC-MS, ICP-MS, NMR, XRPD, DSC, TGA, and particle characterization tools.
- Design, execute, and interpret extractables and leachables studies for inhalation drug products, packaging systems, and device components.
- Perform toxicological risk assessments and establish analytical evaluation thresholds (AETs) in alignment with regulatory expectations.
- Develop, validate, and troubleshoot analytical methods for characterization of impurities, degradants, extractables, and leachables.
- Support regulatory submissions by preparing scientific justifications, technical reports, protocols, and responses to agency queries.
- Coordinate cross-functional activities with formulation, device, packaging, quality, and regulatory teams.
- Review data, ensure compliance with GMP, GDP, and internal quality standards, and drive continuous improvements in analytical capabilities.




- Mentor team members and provide technical leadership for complex analytical investigations.

Qualifications Experience:

- M. Pharm /M.Sc./Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline.
- 8-10 years of experience in pharmaceutical analytical development, with solid expertise in API characterization and inhalation EL studies.
- Hands-on experience with hyphenated techniques (LC-MS/MS, GC-MS/MS, ICP-MS) and regulatory requirements related to OINDPs.
- Strong scientific writing, problem-solving, and project leadership skills.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Deputy Manager / Manager, Analytical R&D E&L Inhalation (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad