Scientist, Formulation R&D

Amneal Pharmaceuticals, Inc.
  • Piscataway, NJ
  • Autofill and Review
30+ days ago

Job Description

Scientist, Formulation R&D: Develop and optimize formulations for oral solid dosage forms (tablets, capsules, and modified release products). Conducting pre-formulation studies, excipient compatibility assessments, and dissolution profiling. Supporting analytical method development and validation for assay, dissolution, and stability- indicating methods. Design and execute stability studies as per ICH guidelines to establish product shelf life. Perform troubleshooting of formulation and analytical issues during development and scale-up. Collaborate with manufacturing and quality teams for pilot-scale and commercial-scale technology transfer. Prepare technical reports, development documents, and regulatory submission support (ANDA/CTD). Ensure strict adherence to cGMP, GLP, and regulatory requirements throughout the development process.

Numbers & Facts

LocationPiscataway, NJ

Skills

  • Abbreviated New Drug Applicationunmatched
  • Analytical Developmentunmatched
  • Analytical Method Developmentunmatched
  • Analytical Method Validationunmatched
  • Assaysunmatched
  • Capsulesunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Dosage Formsunmatched
  • GLP (Good Laboratory Practices)unmatched
  • ICH Regulationsunmatched
  • Identify Issuesunmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Regulatory Requirementsunmatched
  • Regulatory Submissionsunmatched
  • Reporting Skillsunmatched
  • Research & Development (R&D)unmatched

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