Team Leader - Synthesis R&D

Key Responsibilities

A. Critical Responsibilities

1. Evaluate process feasibility, route selection, scalability and manufacturing cost.
2. Optimise processes using DoE and QbD to identify CPPs and minimise scale-up risks.
3. Lead scale-up trials, technology transfer and troubleshooting at manufacturing sites.
4. Improve process yields, product quality, cycle time and cost efficiency.
5. Prepare feasibility, process development, optimisation and scale-up reports.
6. Identify, characterise and prepare process-related, degradation and genotoxic impurities (GTIs).

B. Important Responsibilities

1. Ensure compliance with SOPs, regulatory guidelines, GLP and documentation requirements.
2. Conduct technology transfer experiments and provide technical data to relevant departments.
3. Ensure laboratory safety, chemical handling and environmental compliance.
4. Coordinate with Manufacturing, QA, QC, Analytical R&D and Engineering teams.

C. Other Responsibilities

1. Lead and develop the R&D team and monitor technical progress.
2. Ensure laboratory equipment maintenance, calibration and proper utilisation.
3. Promote professional conduct, effective communication and continuous process improvement.

Key Expected Outcomes

1. Scalable, cost-effective API processes with improved yields and quality.
2. Successful technology transfer with minimal scale-up issues.
3. Effective impurity control and regulatory compliance.
4. Timely project completion, accurate documentation and effective team performance.