Laboratory Scientist/Engineer 2

FUJIFILM Holdings America Corporation; Northern (KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies is seeking a Laboratory Scientist/Engineer 2 to support bench-scale bioreactor studies and downstream purification, enabling scale-up and tech transfer to GMP manufacturing. The role partners with internal and external teams and may require off-hours during critical runs.

The candidate should have a degree in a related field and hands-on experience with CHO/mammalian cell culture, chromatography skids, and data analysis, with a focus on ALCOA+ data integrity.

Qualifications

• Bachelor’s or advanced degree in Chemical Engineering, Bioengineering, Biotechnology, Biology required.
• 2+ years of industry experience in upstream mammalian cell culture and downstream purification.
• Hands-on experience with chromatography skids and ÄKTA/UNICORN tooling.

Responsibilities

• Plan, execute, and troubleshoot bench-scale upstream mammalian cell culture in bioreactors.
• Perform downstream purification including chromatography and UF/DF.
• Generate data packages to enable scale-up and tech transfer to clinical and commercial manufacturing.
• Draft and revise study protocols and SOPs; support CAPAs in MSAT lab context.
• Support equipment qualification, calibration, and EHS/compliance.

Skills

Mammalian cell culture

Chromatography

UPSTREAM/DOWNSTREAM

ÄKTA/UNICORN

Data analysis (JMP/Minitab/Python)

Education

Bachelor’s or advanced degree in Chemical Engineering, Bioengineering, Biotechnology, Biology

Tools

ÄKTA/UNICORN

TFF (UF/DF)

Job description

Position Overview

The Laboratory Scientist/Engineer 2 is part of a manufacturing science lab that serves as the first point of entry for external client processes to execute process establishment runs within a tech transfer framework. This position plans and executes bench-scale bioreactor studies (up to ~5 L fed-batch) and performs downstream purification, including chromatography and ultrafiltration/diafiltration (UF/DF). The role also generates data packages that enable scale-up and tech transfer to clinical and commercial manufacturing. The Laboratory Scientist 2 supports bridging studies, satellite runs, and ad-hoc investigations for large-scale manufacturing in close collaboration with internal partners and external clients. This role may require occasional off-hours/weekend support during critical runs, harvests, or purifications.

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

What You'll Do:

• Plans, executes, and troubleshoots upstream mammalian cell culture studies in bench-top bioreactors (e.g., Sartorius BIOSTAT), including seed trains, media/buffer prep, inoculations, daily sampling, and aseptic manipulations in biosafety cabinets
• Performs downstream purification operations: column chromatography (e.g., ProA, IEX, HIC), column packing, skid setup, and method execution (e.g., ÄKTA/UNICORN), in-process pooling, and UF/DF by tangential flow filtration (TFF) systems with appropriate membranes
• Executes harvest operations (centrifugation/filtration), clarification, virus inactivation/filtration (as applicable to process design), and final formulation at bench scale
• Generates data packages that enable scale-up and tech transfer to clinical and commercial manufacturing
• Collects customer support samples from the GMP manufacturing floor and processes these samples for further shipment to external clients
• Drafts and revises study protocols and standard operating procedures (SOPs); contributes to investigations, deviations, and corrective and preventive actions (CAPAs) within the MSAT lab context
• Supports implementation and qualification of new lab equipment and technologies; maintains lab readiness (instrument calibration, preventive maintenance, inventory, 5S, and Environmental Health and Safety (EHS) compliance); upholds ALCOA+ data integrity
• Supports bridging studies, satellite runs, and ad-hoc investigations for large-scale manufacturing in close collaboration with internal partners and external clients; supports technology transfer from external partners into GMP manufacturing
• Performs other duties as assigned

Minimum Requirements:

• Bachelor’s or advanced degree in Chemical Engineering, Bioengineering, Biotechnology, Biology, or related field with2+years of relevant industry experience spanning both upstream mammalian cell culture and downstream purification
• Hands-on experience with chromatography skids and software (e.g., ÄKTA/UNICORN), column packing, method execution, and troubleshooting
• Experience with CHO or other mammalian cell lines
• Demonstrated UF/DF (TFF) experience, including membrane selection, TMP/flux control, hold-up, and recovery optimization
• Experience with JMP/Minitab/Python, basic statistics, and DOE exposure

Preferred Requirements:

• Experience supporting technology transfer

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 ([e-mail]).