Senior Upstream Bioprocess Scientist | Tech Transfer Lead

FUJIFILM; Holly Springs (MS); On-site; USD 120,000 - 180,000; Full time

Job summary

FUJIFILM Biotechnologies in North Carolina is seeking an experienced Upstream Process Engineer to support lab and pilot-scale development, technology transfers, and collaboration with Manufacturing. You will lead DOE and SPC-driven analyses, troubleshoot deviations, and drive GMP-compliant process validation and transfer activities across unit operations.

The role requires advanced degrees and several years of experience in bioprocess development; strong communication and cross-functional

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, and CAPA in response to deviations
• Lead technology transfer across multiple upstream unit operations
• Coordinate, plan, and execute manufacturing process validation runs
• Collaborate with Manufacturing to support campaigns
• Write and review master batch records (MBRs) and SOPs as needed
• Lead training of manufacturing and process science staff on new processes

Skills

Design of Experiments (DOE)

Statistical Process Control (SPC)

Problem solving

Data analysis

Project management

Communication

Cross-functional collaboration

Education

Associate degree in Engineering, Life Science, or Chemical Engineering

Bachelor’s degree in Engineering, Life Science, or Chemical Engineering

Master’s degree

PhD

Tools

Deviation management systems

Change control systems

CAPA documentation systems

Document management

Job description

FUJIFILM Biotechnologies in North Carolina is seeking an experienced Upstream Process Engineer to support lab and pilot-scale development, technology transfers, and collaboration with Manufacturing. You will lead DOE and SPC-driven analyses, troubleshoot deviations, and drive GMP-compliant process validation and transfer activities across unit operations.

The role requires advanced degrees and several years of experience in bioprocess development; strong communication and cross-functional