Laboratory Scientist/Engineer 2

FUJIFILM; Holly Springs (NC); Vor Ort; USD 80.000 - 110.000; Vollzeit

Zusammenfassung

FUJIFILM Biotechnologies in Holly Springs, North Carolina is seeking a Laboratory Scientist/Engineer 2 to advance bench-scale bioreactor studies and downstream purification within a tech transfer framework.

You will design and execute upstream cell culture and purification workflows, generate data packages for scale-up, and support tech transfer to clinical and commercial manufacturing. The role may require occasional off-hours during critical runs.

Qualifikationen

• Bachelor’s or advanced degree in Chemical Engineering, Bioengineering, Biotechnology, Biology with 2+ years of relevant industry experience spanning both upstream mammalian cell culture and downstream purification.
• Hands-on experience with chromatography skids and software (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.

Aufgaben

• Plan, execute, and troubleshoot upstream mammalian cell culture studies in bench-top bioreactors, including seed trains, media prep, inoculations, sampling, and aseptic manipulations.
• Perform downstream purification operations: column chromatography, column packing, in-process pooling, and UF/DF using TFF systems.
• Execute harvest operations, clarification, virus inactivation/filtration as applicable, and final formulation at bench scale.
• Generate data packages to support scale-up and tech transfer to clinical and commercial manufacturing.
• Collect customer samples from GMP manufacturing floor and process for shipment to external clients.
• Draft and revise study protocols and SOPs; contribute to investigations, deviations, and CAPAs in MSAT lab context.
• Support implementation and qualification of new lab equipment; maintain lab readiness and 5S/EHS compliance; ensure ALCOA+ data integrity.
• Support bridging studies, satellite runs, and ad-hoc investigations for large-scale manufacturing; assist tech transfer from external partners into GMP manufacturing.
• Perform other duties as assigned.

Kenntnisse

Mammalian cell culture

Chromatography troubleshooting

UF/DF (TFF) experience

Data analysis basics

DOE exposure

Ausbildung

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

Tools

ÄKTA/UNICORN

JMP

Minitab

Python

Jobbeschreibung

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]).