Lead Upstream Bioprocess Scientist - Tech Transfer

Fujifilm; Holly Springs (NC); On-site; USD 120,000 - 170,000; Full time

Job summary

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

Qualifications

• 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.

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.
• 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.

Skills

DOE

SPC

Data analysis

Risk management

Education

Associate degree

Bachelor's degree

Master's degree

PhD

Job description

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