Amneal Pharmaceuticals
Scientist, Formulation R&D
Piscataway, NJ, United States
Sponsorship not specifiedDetected 6 days ago
GMP
About the role
- Conducting pre-formulation studies, excipient compatibility assessments, and dissolution profiling.
- Supporting analytical method development and validation for assay, dissolution, and stability- indicating methods.
Responsibilities
- Develop and optimize formulations for oral solid dosage forms (tablets, capsules, and modified release products).
- 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).
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