Kbi: – Manufacturing Sciences Engineer II

Position 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 early-mid stage clinical manufacturing programs
• Supporting 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, deviations and process/product impact assessments, change controls, and CAPAs
• Compiling/collecting and analyzing process data and communicating out to the client and upper management via production updates and campaign summary reports 
• Supporting/leading 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 

The candidate should be able to apply engineering principles in-order 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 minimal supervision, as well as with teams.  The candidate should also possess excellent communication skills.

Position Responsibilities: 

• Lead technical transfer of new processes into manufacturing and conduct facility fit, author PFDs, develop time in plant estimates and define equipment selection.
• Author / Review technical documents including supporting batch records, formulation/solution/media records, item specifications, project reports, and engineering specifications.  
• Lead technical deviation investigations and collaborate with Operations, Technical and Quality Management to determine event impact, perform root-cause analysis and corrective action identification
• Bill of Material (BOM) generation for new process introductions as well as updating BOMs for process modifications. 
• Author and revise Material Specifications in accordance with compendia requirements and meeting grade requirements for introduced process.
• Determine equipment sizing, media and solution preparation methods and volumes, and assist in coordinating with vendor.
• Collect, organize, and analyze process data from engineering and manufacturing runs for presentation at project meetings.
• Escort client into manufacturing suites for Person in Plant activities

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

Salary Range: $74,000.00 - $102,300.00

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.  

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.