Engineer, Upstream/Downstream Drug Substance Process Development & Tech Transfer

3 Key Consulting is hiring an Engineer for a consulting engagement with its direct client, a biopharmaceutical company. The role supports upstream and/or downstream drug substance process development, technology transfer, scale-up, and clinical or commercial manufacturing, partnering with manufacturing, quality, analytical, and bench science teams. Responsibilities Transfer processes for drug substance manufacturing and translate process improvements from the laboratory into manufacturing facilitiesProvide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operationAssist in troubleshooting clinical and commercial runsExecute data trending and statistical process analysisSupport technical direction for process-related deviations, CAPAs, and change controlsIdentify and support process-related operational excellence opportunitiesRepresent process development and collaborates with other functions such as Manufacturin