Laboratory Scientist/Engineer 2
Full-time
FUJIFILM Biotechnologies
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: 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
- Bachelor's or advanced degree in Chemical Engineering, Bioengineering, Biotechnology, Biology, or related field with 2+ 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
- Experience supporting technology transfer
Vacancy posted 3 days ago
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