4 - 7 years
5 - 10 Lacs
Posted:2 hours ago|
Platform:
Work from Office
Full Time
1. Develop and optimize cost-effective, scalable, and robust API processes suitable for GMP manufacturing
2. Conduct lab-scale and pilot-scale experiments to evaluate process parameters and critical quality attributes (CQAs)3. Collaborate with R&D, Analytical, QA/QC, and Production teams for successful technology transfer4. Prepare and review technology transfer documents5. Provide on-site support during scale-up and commercial manufacturing, troubleshooting in case of any technical issues6. Ensure compliance with regulatory guidelines (ICH, USFDA, EMA, etc.) during development and transfer7. Identify and implement process improvements to enhance yield, purity and efficiency8. Maintain detailed documentation of experiments, observations and results in accordance with GMP and GLP norms
1. M. Sc. in Organic Chemistry / M.Tech - Chemical with minimum 4-7 year experience in API Process Development and Technology Transfer
2. In depth understanding of QbD principles, process validation and risk assessment tools (e.g. FMEA)3. Strong knowledge of regulatory requirements for API manufacturing and scale-up
4. Excellent communication and cross-functional collaboration skills
5. Ability to troubleshoot and solve technical problems independently
Wockhardt
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