Manufacturing Sciences Engineer II
KBI Biopharma
Durham, NC
Engineering, Information Technology
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:
Minimum Requirements
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
- 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
Minimum 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
- Experience working in a cGMP manufacturing environment is preferred
- Strong proficiency in English and overall communication is required
- Strong engineering and scientific reasoning skills are required
- Strong math skills are required
- Position requires limited physical demands
- Strong computers skills are required particularly in all MS Office programs
- Some equipment operations and testing is required
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
About the company
Company website•Biotechnology Research
KBI Biopharma is an award-winning biopharmaceutical contract services organization providing fully-integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally.
With each of our 500+ client partners, we have worked closely to personalize and rapidly accelerate their drug development programs. Built upon a foundation of world-class analytical capabilities, we deliver efficient process development and clinical and commercial cGMP manufacturing services for mammalian and microbial programs.
KBI is proud to be a JSR Life Sciences Company.