What are the responsibilities and job description for the Scientist, Formulation R&D position at Amneal?
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.
Qualifications:
Requirements: Must have at least a Master’s degree in Pharmacy or Chemistry or Pharmaceutics, or related field. Must have 12 months of experience in the position or in a related position.
Salary: $117K - $120K per annum.
Hours: 40 hrs/wk 8:30am – 5:30pm
Location: Piscataway, NJ