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 experience

Employment 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!