KBI Biopharma

Job Summary:

The Upstream MS&T Principal Engineer will apply sound scientific and engineering principles to successfully transfer, and 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 project/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, scaleup 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 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, 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 implementing solutions that impact the business at a company- wide level
• Leading collaboration on strategic and complex projects or studies with external partners (i.e. process development, vendors), and providing technical guidance at the department level.
• Presenting results in technical reports and internal and external (industry technical conference) presentations
• Supporting IND and BLA filing, and providing guidance with US, EU, and ICH regulations and guidelines

Job Responsibilities:

• Lead technical transfer of new processes into manufacturing and conduct facility fit, author PFDs, develop time in plant estimates and define equipment selection. Determine equipment sizing, media and solution preparation methods and volumes, and assist in coordinating with vendor:
• Author / Review technical documents including supporting batch records, solution/media records, project reports manufacturing process calculations templates, user requirements specifications, etc:
• Lead technical deviation investigations and collaborate with Manufacturing, Investigators and QA to determine event impact, perform root-cause analysis and corrective action identification and implementation:
• Evaluate new technologies and optimization approaches to improve manufacturing operations:
• 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:
• Design and develop program-specific risk assessments and studies to facilitate enrollment and meet validation or production requirements:
• 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:

Knowledge, Skills, Abilities

• BS in Science or Engineering with minimum of 11+ years industry experience, Master’s with 9+ years industry experience, or PhD 7+ years industry experience.
• Extensive expertise in upstream processing techniques and equipment in biologics
• Extensive expertise in technical transfer, scale up and equipment design is required including new technologies and process optimization approaches to manufacturing operations
• Knowledge of industry best practices, guidelines and/or regulations related to process validation (PDA/ICH/BPOG) and requirements of regulatory authorities (FDA/ICH/EMA/PICS) is required
• Extensive experience with GMP compliance requirements
• Working knowledge of Process Development and technical knowledge supporting IND development and GMP production
• Experience working in a cGMP manufacturing environment in a technical or engineering role is required

Language Ability

• Strong proficiency in English and overall communication is required

Reasoning Ability

• Strong engineering and scientific reasoning skills are required

Math Ability

• Strong math skills are required

Computer Skills

• Strong computers skills are required particularly in all MS Office programs

Equipment Use

• Some equipment operations and testing is required

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.