Formulation R&D

Job Responsibilities

• 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.
• Pre-formulation & Compatibility Studies
• Conduct pre-formulation studies to evaluate properties such as solubility, hygroscopicity, flow, and compressibility.
• Perform drugexcipient compatibility studies using thermal and analytical methods (e.g., DSC, FTIR).
• 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.
• 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.
• 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.