Scientist, Formulation R&D

Amneal • Piscataway Township, NJ

1d • $117,000 - $120,000

About The Position

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

• Experience in developing and optimizing formulations for oral solid dosage forms (tablets, capsules, and modified release products).
• Proficiency in conducting pre-formulation studies, excipient compatibility assessments, and dissolution profiling.
• Experience in supporting analytical method development and validation for assay, dissolution, and stability-indicating methods.
• Ability to design and execute stability studies as per ICH guidelines.
• Skills in troubleshooting formulation and analytical issues during development and scale-up.
• Experience collaborating with manufacturing and quality teams for technology transfer.
• Ability to prepare technical reports, development documents, and regulatory submission support (ANDA/CTD).
• Knowledge of cGMP, GLP, and regulatory requirements.

Responsibilities

• Develop and optimize formulations for oral solid dosage forms (tablets, capsules, and modified release products).
• Conduct pre-formulation studies, excipient compatibility assessments, and dissolution profiling.
• Support 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level