
Research Scientist
20 hours ago
Role & responsibilities
- Develop and optimize cost-effective, scalable, and robust API processes suitable for GMP manufacturing
- Conduct lab-scale and pilot-scale experiments to evaluate process parameters and critical quality attributes (CQAs)
- Collaborate with R&D, Analytical, QA/QC, and Production teams for successful technology transfer
- Prepare and review technology transfer documents
- Provide on-site support during scale-up and commercial manufacturing, troubleshooting in case of any technical issues
- Ensure compliance with regulatory guidelines (ICH, USFDA, EMA, etc.) during development and transfer
- Identify and implement process improvements to enhance yield, purity and efficiency
- Maintain detailed documentation of experiments, observations and results in accordance with GMP and GLP norms
Desired candidate profile :
- M. Sc. in Organic Chemistry / M.Tech - Chemical with minimum 4-7 year experience in API Process Development and Technology Transfer
- In depth understanding of QbD principles, process validation and risk assessment tools (e.g. FMEA)
Strong knowledge of regulatory requirements for API manufacturing and scale-up
Excellent communication and cross-functional collaboration skills
Ability to troubleshoot and solve technical problems independently
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