Deputy Manager / Manager, Analytical R&D E&L Inhalation
Amneal Pharmaceuticals · Ahmedabad · onsite · Posted 42d ago
Undisclosed8–10 yrsfulltimeSourced from
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About this 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 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.
Sourced from naukri
Skills
Technical LeadershipAnalytical Developmentregulatory submissionsChemistrycharacterizationPharmaceutical SciencesTGAcompliancePharmaceutical
About Amneal Pharmaceuticals
Amneal Pharmaceuticals
Pharma
5.5k+
employees
2002
24 years old
Bridgewater, New Jersey
United States (USA)
About
Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.
Industries
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