FSP Scientist
Core
Execute downstream process development studies for biopharmaceutical drug-substance manufacture, focusing on chromatography and filtration operations.
Role type
Scientist (Downstream Process Development)
Builds
Biopharmaceutical drug substances
Domain
Biopharmaceuticals / Downstream Processing
Required skills
Chromatography operations, Filtration operations, Experimental design, Data analysis, Troubleshooting, Process scale-up, Technology transfer, Documentation
Preferred skills
Statistical analysis, Equipment maintenance, Cross-functional collaboration
Technologies
Chromatography systems, Filtration units, Laboratory equipment
Responsibilities
Plan and execute downstream process-development studies across unit operations such as capture, intermediate and polishing chromatography, depth filtration, viral filtration, and ultrafiltration/diafiltration. Analyze experimental and process data using appropriate statistical, digital, and visualization tools. Identify and troubleshoot technical and experimental issues affecting chromatography, filtration, recovery, impurity clearance, process robustness, or equipment performance. Contribute to studies supporting process optimization, robustness, scale-up, small-scale model qualification, process characterization, and technology transfer. Maintain complete, accurate, contemporaneous, and traceable experimental records in the applicable approved systems. Collaborate with upstream development, analytical, formulation, MSAT, manufacturing, Quality, Regulatory, and CMC partners as required by the assigned downstream work.
