- Formulation Development:
- Design and optimize OSD formulations (tablets, capsules, granules) for recent products and line extensions.
- Conduct pre-formulation studies and compatibility assessments.
- Technology Transfer:
- Prepare and review TT documents including product development reports, batch manufacturing records, and validation protocols.
- Coordinate with manufacturing, QA, QC, and regulatory teams to ensure smooth transfer of products.
- Documentation & Compliance:
- Maintain accurate records of experiments, trials, and TT activities.
- Ensure adherence to cGMP, ICH, and other regulatory guidelines.
- Troubleshooting & Support:
- Provide technical support during scale-up, exhibit batches, and commercial manufacturing.
- Investigate and resolve formulation or process-related issues.