Deputy Manager / Manager, Analytical R&D E&L Inhalation
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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.
About Amneal India
Developer and manufacturer of generic and specialty pharmaceutical products.
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