MS&T Upstream Principal Engineer

Job Summary

The Upstream MS&T Principal Engineer will apply sound scientific and engineering principles to successfully transfer, enroll, and manage new biopharmaceutical processes into the cGMP manufacturing facility. The scope of this role includes :

• Leading and providing guidance on multiple technical transfer projects for highly challenging mid-late stage clinical and commercial manufacturing programs and commercial programs
• Leading multiple commercial projects / products as process steward, and leading supporting activities for process validation
• 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 of bill of materials (BOM) and new item specifications
• Providing supervisory and 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 / collecting and analyzing process data, experimental study data (e.g., multivariate analysis), and communicating updates to the client and upper management via production updates and campaign summary reports
• Leading complex investigational and troubleshooting efforts and implementing solutions that impact the business at a company-wide level
• Leading collaboration on strategic and complex projects or studies with external partners (e.g., process development, vendors), and providing technical guidance at the department level
• Presenting results in technical reports and in internal and external presentations (industry technical conferences)
• Supporting IND and BLA filing, and providing guidance with US, EU, and ICH regulations and guidelines

Job Responsibilities

Minimum Requirements

Language Ability

Reasoning Ability

Math Ability

Computer Skills

Equipment Use

Range : $133,000.00 / yr - $183,700.00 / 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.

J-18808-Ljbffr