Manufacturing Sciences Engineer II

KBI Biopharma•Durham, NC

22h•Onsite

About The Position

The Upstream MS&T Engineer II 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 clinical manufacturing programs Supporting and/or driving 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, scaleup calculations, defining equipment and solution requirements, and generation of bill of materials (BOM) and new item specifications Providing technical support for cGMP production runs, CAPAs, process and product impact assessments for deviations and change controls Providing supervisory and technical support for cGMP production runs, deviations and process/product impact assessments, change controls, and CAPAs Providing supervisory and technical support during technical document execution, new equipment testing, water runs in manufacturing. Compiling/Collecting and analyzing process data and communicating out to the client and upper management via production updates and campaign summary reports Supporting/leading complex investigational and troubleshooting efforts and providing recommendations to manufacturing for implementation Supporting/leading collaboration on strategic projects or studies with external partners (i.e. process development, vendors) and presents results in technical reports

Requirements

BS in Science or Engineering with minimum of 4 years industry experience, Master’s with 2 years industry experience or PhD with no years industry experience.
Expertise in upstream and/or downstream processing techniques and equipment in biologics.
Experience with technical transfer and scale up is required.
Experience with GMP compliance requirements.
Working knowledge of Process Development and technical knowledge supporting IND development and early phase GMP production.
Strong proficiency in English and overall communication is required.
Strong engineering and scientific reasoning skills are required.
Strong math skills are required.
Strong computer skills are required particularly in all MS Office programs.

Nice To Haves

Experience working in a cGMP manufacturing environment is preferred.

Responsibilities

Apply sound scientific and engineering principles to successfully transfer and enroll new biopharmaceutical processes into the cGMP manufacturing facility.
Lead technical transfer projects for platform and/or repeat clinical manufacturing programs.
Support and/or drive business decisions and operations related to facility fit, time in plant and new technologies or equipment and communicate recommendations to the client.
Perform facility fit activities including process flow diagram generation, scaleup calculations, defining equipment and solution requirements, and generation of bill of materials (BOM) and new item specifications.
Provide technical support for cGMP production runs, CAPAs, process and product impact assessments for deviations and change controls.
Provide supervisory and technical support for cGMP production runs, deviations and process/product impact assessments, change controls, and CAPAs.
Provide supervisory and technical support during technical document execution, new equipment testing, water runs in manufacturing.
Compile/Collect and analyze process data and communicate out to the client and upper management via production updates and campaign summary reports.
Support/lead complex investigational and troubleshooting efforts and provide recommendations to manufacturing for implementation.
Support/lead collaboration on strategic projects or studies with external partners (i.e. process development, vendors) and present results in technical reports.
Apply engineering principles in-order to problem solve and drive projects to successful completion within defined timelines.
Manage multiple projects and resources.
Work independently and with teams.
Operate and test some equipment.