About the role
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 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.
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
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