Scientist 3Engineer 3, MSAT

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 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 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: 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
• Bachelors degree in Engineering Life Science or Chemical Engineering with 6 years of related work experience (e.g. manufacturing); or
• Masters 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

EEO Information

Fujifilm is committedto 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 ().

Required Experience:

IC