Position Summary

The Upstream MS&T Senior Engineer will apply sound scientific and engineering principles to successfully transfer and enroll new biopharmaceutical processes into the GMP manufacturing facility.

Position Responsibilities

• Leading and providing guidance on multiple technical transfer projects for challenging mid and late stage clinical manufacturing programs and commercial programs.
• Leading commercial project/product as a process steward and leading supporting activities for process validation.
• Driving business decisions and operations related to facility fit, time in plant, new technologies or equipment, and communicating recommendations to the client.
• Managing junior engineers (direct line reporting)
• Performing facility fit activities including process flow diagram generation, scale up calculations, defining equipment and solution requirements, generation of bills of materials, and new item specifications.
• Providing supervisory and technical support for GMP production runs, deviations and process/product impact assessments, change controls, and CAPAs
• Compiling/analyzing process data, experimental study data (i.e. multivariate analysis), 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 and complex projects or studies with external partners (i.e. process development or vendors), technically guides other engineers, presents results in technical reports, and internal and external (industry technical conference) presentations.
• Supporting IND and BLA filings.
• Providing guidance with US, EU, and ICH regulations and guidelines.

Position Requirements

• BS in Science or Engineering with minimum of 9 years industry experience, Masters with 7 years industry experience, PhD with 6 years industry experience.
• Extensive 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 regulatory agencies is required.
• Experience with GMP compliance requirements
• Working knowledge of Process Development and technical knowledge supporting IND development and early phase GMP manufacturing
• Experience working in a GMP manufacturing environment.

Range: $118,000.00 / yr - $162,800.00 / 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.