Job Summary:

The Engineer III 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 off-platform and late stage clinical programs
• 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, 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.
• Leading complex investigational and troubleshooting efforts and providing recommendations to manufacturing for implementation
• Leading collaboration on strategic projects or studies with external partners (ie. process development, vendors) and presents results in technical reports or wider industry publications

Job Requirements:

Knowledge, Skills, Abilities

• BS in Science or Engineering with minimum of 7 years industry experience or Masters with 5 years industry experience or PhD with 3 years industry experience
• Expertise in upstream and/or downstream processing techniques and equipment in biologics
• Expertise in technical transfer and scale up is required
• Knowledge of industry best practices is preferred including equipment design, process technologies, process validation and requirements of boards of health (health authorities)
• Experience with GMP compliance requirements
• Working knowledge of Process Development and technical knowledge supporting IND development and early phase GMP production
• Working knowledge of late stage and commercial programs is an added bonus
• Experience working in a cGMP manufacturing environment is preferred

Salary Range: $101,000.00 / yr - $138,600.00 / yr

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. 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.

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.