Laboratory Scientist/Engineer 2
FUJIFILM Biotechnologies
Summary
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.
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 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
Preferred Requirements
- Experience supporting technology transfer
Requirements
- Bachelor’s or advanced degree in Chemical Engineering, Bioengineering, Biotechnology, Biology, or related field
- 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
Company overview
FUJIFILM Biotechnologies is a specialized biotechnology division of FUJIFILM Corporation, leveraging the company's extensive expertise in imaging and materials science to develop innovative bioprocessing solutions. The company focuses on advancing cell culture technologies, bioprocessing equipment, and contract development and manufacturing services for the biopharmaceutical industry. With a strong emphasis on research and development, FUJIFILM Biotechnologies provides comprehensive solutions for cell line development, process optimization, and manufacturing scale-up. The company integrates FUJIFILM's proprietary technologies in filtration, separation, and analytical systems to enhance bioprocessing efficiency and product quality. Their offerings support the development and production of biologics, vaccines, and cell therapies, serving pharmaceutical companies and research institutions worldwide. The organization combines Japanese precision engineering with global biotech innovation to address complex challenges in biomanufacturing and therapeutic development.