Formulation Research and Development - FRD

Role & responsibilities

• Formulation Development for oral solid dosage form including tablets, capsules and oral liquids
• Execute development, scale-up and exhibit batch activities
• Optimize formulations for stability, bioavailability and manufacturability
• Develop QbD based formulation strategies and support regulatory documentation
• Respond to regulatory queries for global market
• Cost efficient API and excipient implementation
• In-dept understanding of SOD design and optimization
• Strong knowledge of QbD, DOE and process close-up
• Experience with regulatory guidelines(FDA, EMA, HC & ICH)
• Excellent problem solving, documentation and communication skills
• Collaborate with analytical QA, PDL and regulatory teams to ensure successful product development technology transfer
• Good exposure to IR, ER, DR, MR, SR Formulations