Process Development Engineer, upstream drug substance (JP13223)

Process Development Engineer, Upstream Drug Substance position at 3Key Consulting for a consulting engagement with a leading global biotechnology company.

Requirements

• Process engineering support for human therapeutic products in clinical development through commercial production
• Transfer purification drug substance processes and performs process improvements
• Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
• Offer process validation support for late stage commercial processes
• Provide routine process monitoring and troubleshooting
• Execute data trending and statistical process analysis
• Support technical direction for process related deviations, CAPAs and change controls
• Identify and support process related operational excellence opportunities
• Represent process development and collaborate with other functions such as Manufacturing, Quality, and Regulatory