Scientist, Formulation R&D

Amneal Pharmaceuticals Inc

Piscataway, NJ

JOB DETAILS
SALARY
$117,000–$120,000 Per Year
SKILLS
Abbreviated New Drug Application, Analytical Development, Analytical Method Development, Analytical Method Validation, Assays, Capsules, Chemistry, Current Good Manufacturing Practice (cGMP), Dosage Forms, GLP (Good Laboratory Practices), ICH Regulations, Identify Issues, Maintain Compliance, Manufacturing, Pharmaceutics, Pharmacy, Regulatory Requirements, Regulatory Submissions, Reporting Skills, Research & Development (R&D)
LOCATION
Piscataway, NJ
POSTED
12 days ago

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.

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

About the Company

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Amneal Pharmaceuticals Inc