Scientist, Downstream Process Scale-Up
Core
Lead the execution and scale-up of downstream purification manufacturing for AAV viral vectors from 50-L pilot through 2000-L scale.
Role type
Senior IC downstream process scientist (biologics/viral vectors)
Builds
Robust and efficient purification processes for high-dose gene therapy products
Domain
Biopharma / Gene Therapy / Viral Vector Manufacturing
Required skills
Chromatography, Tangential Flow Filtration (TFF), SOP authoring, batch record management, pilot-scale manufacturing, large-scale manufacturing, troubleshooting, process technology transfer, risk assessment, UV spectrophotometry, DLS particle sizing
Preferred skills
Depth Filtration, Viral Filtration/Inactivation, AAV purification development, CMC and drug development, digital manufacturing solutions, product comparability, quality risk assessment
Technologies
Chromatography, TFF, Depth Filtration, Viral Filtration, UV spectrophotometry, DLS
Responsibilities
Lead execution and scale-up of downstream purification from pilot to large scale; Author, review, and revise SOPs and batch records; Perform data analyses and contribute to technical reports; Troubleshoot manufacturing issues; Maintain critical process equipment and evaluate new technologies; Support digital transformation initiatives; Mentor junior staff
Seniority
Senior, hands-on IC
