Formulation R&D

As a Formulation Design & Development Scientist, your role will involve designing and developing robust, scalable formulations for oral solid dosage forms (OSDs) such as tablets, capsules, and granules. You will be responsible for selecting appropriate excipients, processing techniques (e.g., direct compression, wet/dry granulation), and equipment. Your key responsibilities will include: - Developing formulations that align with target product profiles (QTPP), ensuring considerations for bioavailability, stability, and manufacturability. - Conducting pre-formulation studies to assess properties like solubility, hygroscopicity, flow, and compressibility. - Performing drug-excipient compatibility studies using thermal and analytical methods (e.g., DSC, FTIR). - Planning, executing, and supervising laboratory-scale, exhibit, and pilot batches. - Operating and troubleshooting equipment including blenders, granulators, tablet compression machines, capsule fillers, and coating pans. - Ensuring compliance with cGMP standards during batch execution. - Optimizing manufacturing processes utilizing tools like QbD and DoE. - Establishing process parameters and critical process attributes (CPAs, CPPs). - Evaluating scalability and reproducibility for commercial manufacturing. - Designing and initiating stability studies in accordance with ICH guidelines. - Coordinating with the analytical department for timely sample analysis and review of results. - Monitoring product behavior under various storage conditions and recommending formulation/process changes if necessary. In addition to your responsibilities, if there are any additional details about the company in the job description, please provide that information.,