Job Description

Position Overview

The Upstream Engineer/Scientist 2 will provide tech transfer support and technical oversight for a large-scale cell culture in monoclonal antibody manufacturing.

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

Job Description

What You’ll Do

• Conducts lab and pilot plant experiments
• Generates and coordinates execution sampling protocols
• Serves as subject matter expert (SME) to lead and conduct troubleshooting, process impact assessments, and executes root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviations
• Executes and analyzes lab and pilot plant work aimed at solving complex manufacturing problems
• Leads and supports technology transfer (TT) across multiple unit operation
• Coordinates, plans, and executes manufacturing process validation runs
• Supports design and leads generation of sampling plans for process validation reports (PVRs) and investigations
• Writes and reviews master batch records (MBRs) and standard operating procedures (SOPs), as needed
• Generates and executes process training and consults on topics related to manufacturing and process
• Leads technical risk assessments for new manufacturing processes
• Contributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at both process monitoring and continued process verification
• Writes documentation for internal and external use, such as manufacturing campaigns summary reports, process performance qualification (PPQ) protocol and reports, impact assessments etc.
• Leads training of manufacturing staff and process sciences group on new processes, procedures, and use of equipment in the lab
• Interprets and utilizes new knowledge to promptly drive data-based decisions
• Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support
• Leads continuous improvement projects within unit operations, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and cost
• Supports supplier technical evaluations, risk assessments, and raw material evaluation and qualification
• Other duties, as assigned

Knowledge and Skills

• Proficient knowledge in Design of Experience (DOE)
• Proficient knowledge in Statistical Process Control
• Effective communication, both written and oral
• Ability to effective present information to others
• Proficient project management skills
• Advanced problem-solving skills
• Ability to provide feedback to others, including leaders
• Ability to develop effective working relationships internally and externally
• Ability to adapt communication style to differing audiences and advise others on difficult matters

Basic Requirements

• Associate degree in Engineering, Life Science or Chemical Engineering with 4 years of related work experience (e.g., manufacturing); or
• Bachelor’s degree in Engineering, Life Science or Chemical Engineering with 2 years of related work experience (e.g., manufacturing); or
• Master’s degree with no prior experience
• Experience using quality systems (e.g., deviation management, change control, CAPA, document management system)
• Experience in contract manufacturing or interacting with contract manufacturers

Preferred Requirements

• Experience working in a Good Manufacturing Practices (GMP) environment

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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