Manufacturing Sciences Engineer II

JOB SUMMARY 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 during technical document execution, new equipment testing, and water runs in manufacturing Compiling and analyzing process data and communicating it to the client and upper management via production updates and campaign summary reports Supporting and leading complex investigational and troubleshooting efforts and providing recommendations to manufacturing for implementation Supporting and leading collaboration on strategic projects or studies with external partners (e.g., process development, vendors) and presenting results in technical reports JOB RESPONSIBILITIES The candidate should be able to apply engineering principles to problem‑solve and drive projects to successful completion within defined timelines. The ability to manage multiple projects and resources is required. The candidate should have the ability to work independently and with teams and possess excellent communication skills. MINIMUM REQUIREMENTS BS in Science or Engineering with a minimum of 4 years industry experience, a Master’s with 2 years industry experience, or a Ph.D. with no industry experience requirement Expertise in upstream and/or downstream processing techniques and equipment in biologics Experience with technical transfer and scale‑up Experience with 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 Strong proficiency in English and overall communication Strong engineering and scientific reasoning skills Strong math skills Position requires limited physical demands Strong computer skills, particularly in all MS Office programs Some equipment operations and testing is required EEO STATEMENT KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. #J-18808-Ljbffr