03 Nov
|
Metrochem API Private
|
Hyderabad
03 Nov
Metrochem API Private
Hyderabad
Key Responsibilities
A. Critical Responsibilities
• Evaluate process feasibility, route selection, scalability and manufacturing cost.
• Optimise processes using DoE and QbD to identify CPPs and minimise scale-up risks.
• Lead scale-up trials, technology transfer and troubleshooting at manufacturing sites.
• Improve process yields, product quality, cycle time and cost efficiency.
• Prepare feasibility, process development, optimisation and scale-up reports.
• Identify, characterise and prepare process-related, degradation and genotoxic impurities (GTIs). B. Important Responsibilities
• Ensure compliance with SOPs, regulatory guidelines, GLP and documentation requirements.
• Conduct technology transfer experiments and provide technical data to relevant departments.
• Ensure laboratory safety, chemical handling and environmental compliance.
• Coordinate with Manufacturing, QA, QC, Analytical R&D; and Engineering teams. C. Other Responsibilities
• Lead and develop the R&D; team and monitor technical progress.
• Ensure laboratory equipment maintenance, calibration and proper utilisation.
• Promote qualified conduct, effective communication and continuous process improvement. Key Expected Outcomes
• Scalable, cost-effective API processes with improved yields and quality.
• Successful technology transfer with minimal scale-up issues.
• Effective impurity control and regulatory compliance.
• Timely project completion, accurate documentation and effective team performance.
📌 Deputy Manager (Hyderabad)
🏢 Metrochem API Private
📍 Hyderabad