Support technology transfer activities from R&D; to pilot plant and commercial manufacturing.
- Assist in process scale-up, process optimization, and validation activities for API products.
- Coordinate with Production, QA, QC, Engineering, and R&D; teams to resolve process-related issues.
- Prepare and review technology transfer documents, process descriptions, batch manufacturing procedures, and technical reports.
- Support process troubleshooting during manufacturing and recommend corrective actions in coordination with relevant departments.
- Participate in process validation, exhibit batches, engineering batches, and process improvement activities.
- Review batch manufacturing records and investigate process deviations in coordination with QA and Production.
- Ensure compliance with GMP, SOPs, safety guidelines, and applicable regulatory requirements.
- Support yield improvement, cycle-time reduction, solvent recovery, and cost-optimization initiatives.
- Maintain technical documentation and provide support during internal, customer, and regulatory audits.