Principal Scientist, Downstream Process Development

📋 Description

• Support late-stage AAV downstream process development and optimization.
• Lead purification development: chromatography (AFF, IEX) and filtration (depth, NFF, TFF).
• Author protocols/reports; perform process characterization and validation (FMEA, scale-down, DOE/OFAT, PPQ).
• Analyze process/analytical data (Excel, JMP) to identify trends and optimize.
• Present findings to PD and cross-functional CMC teams.
• Collaborate cross-functionally for smooth development-to-commercial transition.

🎯 Requirements

• PhD in Biochemistry/Chemical Engineering/Molecular Biology or related; 6+ yrs downstream PD.
• Experience with AAV/viral vectors, preferably late-stage for clinical/commercial.
• Deep expertise in purification process development and equipment (chromatography, filtration).
• Experience with scalable AKTA, depth filtration, and TFF systems.
• Knowledge of GMP and regulations for gene therapy.
• DOE, process characterization, and BLA enabling activities preferred.
• Experience authoring regulatory submissions (IND/BLA).
• Strong problem-solving and troubleshooting of complex bioprocesses.