promeatherapeutics
Job responsibilities: 1. Formulation Design & Development Design and develop robust, scalable formulations for oral solid dosage forms (OSDs) including tablets, capsules, and granules. Select appropriate excipients, processing techniques (e.g., direct compression, wet/dry granulation), and equipment. Develop formulations that meet target product profiles (QTPP), including bioavailability, stability, and manufacturability. 2. Pre-formulation & Compatibility Studies Conduct pre-formulation studies to evaluate properties such as solubility, hygroscopicity, flow, and compressibility. Perform drug–excipient compatibility studies using thermal and analytical methods (e.g., DSC, FTIR). 3. Experimental Batch Execution Plan, execute, and supervise laboratory-scale, exhibit, and pilot batches. Operate and troubleshoot equipment like blenders, granulators, tablet compression machines, capsule fillers, and coating pans. Ensure compliance with cGMP during batch execution. 4. Process Development & Optimization Optimize manufacturing processes using tools such as QbD and DoE. Establish process parameters and critical process attributes (CPAs, CPPs). Evaluate scalability and reproducibility for commercial manufacturing. 5. Stability Studies Design and initiate stability studies as per ICH guidelines. Coordinate with the analytical department for timely sample analysis and review of results. Monitor product behavior under different storage conditions and recommend formulation/process changes if needed.