Engineer I, - (Downstream MS&T)

KBI Biopharma • Durham, NC

8d

About The Position

Engineer I will apply sound scientific and engineering principles to successfully transfer and enroll new biopharmaceutical processes into the cGMP manufacturing facility. The scope of this role includes: Leading technical transfer projects for platform and/or repeat early-mid stage clinical manufacturing programs Supporting business decisions and operations related to facility fit, time in plant and new technologies or equipment and communicating recommendations to the client Performing facility fit activities including process flow diagram generation, scale-up calculations, defining equipment and solution requirements, and generation bill of materials (BOM) and new pacifications Providing technical support for cGMP production runs, deviations, change controls, and CAPAs Compiling process data and communicating out to the client and upper management via production updates and campaign summary reports. Supporting complex investigational and troubleshooting efforts and providing recommendations to manufacturing for implementation Supporting collaboration on strategic projects or studies with external partners (ie. process development, vendors) and presents results in technical reports or wider industry publications

Requirements

• BS in Science or Engineering with minimum of 2 years industry experience or Masters without industry experience
• Working knowledge of upstream and/or downstream processing techniques and equipment in biologics.
• Understanding GMP compliance requirements
• Working knowledge of Process Development and technical knowledge supporting IND development and early phase GMP production
• Experience working in a cGMP manufacturing environment is preferred
• Experience with technical transfer and scale up is a plus.

Responsibilities

• Leading technical transfer projects for platform and/or repeat early-mid stage clinical manufacturing programs
• Supporting business decisions and operations related to facility fit, time in plant and new technologies or equipment and communicating recommendations to the client
• Performing facility fit activities including process flow diagram generation, scale-up calculations, defining equipment and solution requirements, and generation bill of materials (BOM) and new pacifications
• Providing technical support for cGMP production runs, deviations, change controls, and CAPAs
• Compiling process data and communicating out to the client and upper management via production updates and campaign summary reports.
• Supporting complex investigational and troubleshooting efforts and providing recommendations to manufacturing for implementation
• Supporting collaboration on strategic projects or studies with external partners (ie. process development, vendors) and presents results in technical reports or wider industry publications

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees