Scientist, Formulation R&D

Role: Formulation R&D Scientist focused on developing and optimizing oral solid dosage forms, including tablets, capsules, and modified release products. Main objectives involve pre-formulation studies, excipient compatibility, dissolution profiling, analytical method development and validation, and stability studies per ICH guidelines. Responsibilities include troubleshooting formulation and analytical issues during scale-up, supporting technology transfer to manufacturing and quality teams, and preparing technical and regulatory documentation for submissions like ANDA/CTD. Requirements: Master’s in Pharmacy, Chemistry, Pharmaceutics, or related field; minimum 12 months of relevant experience; strong knowledge of formulation development, analytical techniques, cGMP/GLP standards, and regulatory compliance. Preferred skills include experience with stability studies, regulatory submissions, and scale-up processes. High-value specifics encompass expertise in oral solid dosage development, regulatory support, cGMP adherence, and collaboration with manufacturing/quality teams during pilot and commercial scale projects. Work setup is onsite in Piscataway, NJ, with standard hours; no travel specified.