Deputy Manager / Manager, Analytical R&D E&L Inhalation

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.

• Seniority: Mid Level
• Languages: English