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.

Qualifications

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 strong expertise in API characterization and inhalation E&L 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.

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