Amneal Pharmaceuticals

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

Amneal Pharmaceuticals  •  State of Gujarāt, IN (Onsite)  •  1 day ago
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Job Description

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.

Amneal Pharmaceuticals

About Amneal Pharmaceuticals

Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.

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Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.

Industry
Chemicals & Materials
Company Size
5,001-10,000 employees
Headquarters
Bridgewater, New Jersey
Year Founded
2002
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