Laboratory Scientist/Engineer 2

Fujifilm • Holly Springs, NC

6d • Onsite

About The Position

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.

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

Nice To Haves

• Experience supporting technology transfer

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree