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Scientist, Formulation R&D

Amneal Pharmaceuticals

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Piscataway, NJ
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Job Description

As posted by the hiring company

Job Overview:

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.