Scientist 3/Engineer 3, MSAT

Full-time

FUJIFILM Biotechnologies

Position Overview
Join a team where your upstream expertise directly impacts large-scale biologics production. If you enjoy solving complex challenges, leading technology transfers, and partnering with manufacturing to bring therapies to patients, this role offers the scope, autonomy, and collaboration to make a real difference.
Company Overview
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit:
Job Description
About Us
We are a science-driven biomanufacturing organization focused on delivering high-quality drug substance for commercial and clinical programs. We:
Champion data-driven decision-making and continuous improvement
Foster an inclusive, respectful culture where diverse perspectives drive better outcomes
Partner closely with Manufacturing, Quality, and external stakeholders to ensure reliable, compliant operations
Invest in learning, development, and knowledge sharing to grow our people and capabilities
Responsibilities
Conduct lab and pilot-plant experiments to support upstream development and scale-up
Generate and coordinate execution of sampling protocols for development, validation, and investigations
Serve as a subject matter expert to lead and conduct troubleshooting, process impact assessments, root cause analysis (RCA), and corrective and preventive actions (CAPA) in response to deviations
Execute and analyze lab and pilot work to solve complex manufacturing problems
Lead and support technology transfer across multiple upstream unit operations
Coordinate, plan, and execute manufacturing process validation runs
Support design and lead generation of sampling plans for process validation reports (PVRs) and investigations
Write and review master batch records (MBRs) and standard operating procedures (SOPs), as needed
Generate and execute process training; consult on topics related to manufacturing and process performance
Lead technical risk assessments for new manufacturing processes
Contribute to manufacturing data management (including databasing) and perform statistical analyses for process monitoring and continued process verification
Write documentation for internal and external use, such as campaign summary reports, process performance qualification (PPQ) protocols and reports, and impact assessments
Lead training of manufacturing and process science staff on new processes, procedures, and equipment
Interpret and apply new knowledge promptly to drive data-based decisions
Collaborate with Manufacturing to support commercial and clinical campaigns, including on-floor support
Lead continuous improvement initiatives to enhance manufacturability, reliability, yield, and cost
Support supplier technical evaluations, risk assessments, and raw material evaluation and qualification
Perform other duties, as assigned
Minimum Qualifications
Associate degree in Engineering, Life Science, or Chemical Engineering with 8 years of related work experience (e.g., manufacturing); or
Bachelor's degree in Engineering, Life Science, or Chemical Engineering with 6 years of related work experience (e.g., manufacturing); or
Master's degree with 3 years of related work experience; or
PhD with no prior experience
Preferred Qualifications
Large-scale manufacturing experience with CHO cell processes and monoclonal antibody production
Experience using quality systems (e.g., deviation management, change control, CAPA, document management)
Experience in contract manufacturing or interacting with contract manufacturers
Experience working in a Good Manufacturing Practices (GMP) environment
Prior drug substance and manufacturing experience, including process development, validation, and transfer
Knowledge, Skills, and Abilities
Proficient knowledge of Design of Experiments (DOE) and Statistical Process Control (SPC)
Advanced problem-solving and data analysis skills; experience with risk management and RCA tools
Effective written and verbal communication; strong presentation skills
Proficient project management and the ability to lead cross-functional efforts
Ability to provide constructive feedback and influence stakeholders, including senior partners
Strong collaboration skills; builds effective internal and external relationships
Adapts communication style to differing audiences and advises others on complex matters
Working Environment and Physical Requirements
Typical lab/office environment; no routine requirement for respiratory protection, hearing protection programs, or powered industrial truck operation
Ability to discern audible cues
No routine requirements for lifting thresholds, prolonged standing or sitting, repetitive motions, climbing, operating machinery, or work at heights
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.
EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (View email address on us.fitly.work).

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Vacancy posted 3 days ago

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