AM / DM - Technical Services (TSD)
2 weeks ago
Role & responsibilities
Key Responsibilities:
1. Process Development & Optimization:
- Design, implement, and optimize chemical synthesis and purification processes for APIs.
- Scale-up lab processes to pilot plant and commercial production.
- Improve yield, quality, and cost through continuous process improvements and parameter adjustments.
2. Technology Transfer:
- Execute seamless technology transfer from R&D to Production.
- Prepare and review process documents such as BMRs, validation protocols, and SOPs.
3. Operational & Technical Support:
- Provide on-floor technical support during production campaigns.
- Troubleshoot process deviations, batch failures, and equipment issues.
- Develop solvent recovery processes for commercial products.
- Support automation initiatives in line with GMP and safety compliance.
4. Compliance & Documentation:
- Ensure strict adherence to cGMP, EHS, and regulatory guidelines.
- Maintain detailed documentation including process risk assessments and change controls.
5. Team & Cross-functional Coordination:
- Lead and mentor process engineers/technicians.
- Liaise with QA, QC, EHS, and Production teams to ensure seamless operations.
6. Continuous Improvement:
- Drive cost reduction, cycle time reduction, and energy efficiency initiatives.
- Lead root cause analysis and implement CAPAs (Corrective and Preventive Actions).
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