Formulation Development Consultant

Kelly Science & Clinical is seeking a Formulation Development Consultant for a 12 month contract with a growing company located in Bridgewater, NJ.This role focuses on the end-to-end development, characterization, and scale-up of small molecule formulations, including managing CDMO partnerships and technical documentation in compliance with regulatory standards. Pay: $65-80/hour depending on experienceEmployment Type: Full Time; 12-month contract Job Responsibilities include:Develops and develops formulations and processes for small molecule compounds, supporting all stages from discovery through commercial validation readiness (oral and parental dosage forms).Monitors formulation stability and incompatibility; prepares and analyzes samples using multiple physical and chemical characterization techniques (e.g., TGA/DSC, XRPD, PSD, HPLC/UPLC, UPLC/MS, microscopy, pH).Develops safe and effective formulations for delivering water-insoluble compounds in preclinical and clinical studies using approved vehicles and excipients for various administration routes.Conducts troubleshooting of pre-formulation, formulation, and manufacturing process challenges and recommends potential solutions.Coordinates with internal teams and external partners to ensure timely delivery of formulations for preclinical and clinical studies.Supports pre-formulation, formulation, and manufacturing for drug development and supplies data for technology transfer to contract manufacturers as needed.Summarizes and presents characterization data on formulations in technical reports, regulatory source documents, and presentations prepared and issued in a timely manner.Maintains safe laboratory working conditions and maintains a steady uninterrupted supply of raw materials, reagents, supplies, and any required tools as necessary.Performs other tasks and assignments as needed and specified by management. Qualifications: Master's degree of PhD in Pharmaceutical Science, Chemistry or a related scientific field. 5+ years of experience in formulation and process development within a pharmaceutical, biotechnology or related environment.1+ years of branded drug experience required. Hands-on experience with a wide range of pharmaceutical manufacturing and analytical instruments, including granulators, tablet and capsule machines, mixers, liquid filling equipment, pH meters, dissolution baths, HPLC/UPLC, TGA, DSC, polarized light microscopy, KF, X-ray diffractometer, PSD analyzers, and UPLC/MS.Experience with the preparation of formulations for drug discovery and clinical support by both oral and parental routes of administration.Previous regulatory writing experience strongly preferred. Interested? Please apply today for immediate consideration!