Scientist 3/Engineer 3, MSAT

Fujifilm; Holly Springs (NC); Presencial; USD 120.000 - 170.000; Jornada completa

Descripción de la vacante

FUJIFILM Biotechnologies in Holly Springs, NC seeks a seasoned upstream development expert to drive scale-up, technology transfer, and cross-functional collaboration with Manufacturing, Quality, and external stakeholders. You will champion data-driven decisions and continuous improvement to deliver high-quality drug substance.

The role emphasizes partnership with Manufacturing teams to ensure reliable, compliant operations and to support commercial and clinical campaigns, with a focus on process

Formación

• Associate degree in Engineering, Life Science, or Chemical Engineering with 8 years of related work experience.
• Bachelor's degree in Engineering, Life Science, or Chemical Engineering with 6 years of related work experience.
• Master's degree with 3 years of related work experience.
• PhD with no prior experience.

Responsabilidades

• 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.
• Lead troubleshooting, RCA, CAPA, and deviations responses.
• 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 sampling plan generation for PVRs and investigations.
• Write and review MBRs and SOPs as needed.
• Generate and execute process training; advise on manufacturing and process performance.
• Lead risk assessments for new manufacturing processes.
• Contribute to manufacturing data management and statistical analyses for process monitoring.
• Write documentation for campaigns, PPQ protocols, and impact assessments.
• Lead training of staff on new processes, procedures, and equipment.

Conocimientos

DOE

SPC

Data analysis

Risk management

Educación

Associate degree

Bachelor's degree

Master's degree

PhD

Descripción del empleo

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: https://www.fujifilm.com/us/en/about/region/careers

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