Scientist, Viral Vector Process Development (Downstream)
Core
Design, execute, and optimize scalable Lentiviral Vector (LVV) downstream purification processes for clinical and commercial scales.
Role type
Scientist, Viral Vector Process Development (Downstream)
Builds
Scalable LVV purification processes for ex vivo and in vivo applications
Domain
Cell Therapy / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Downstream process development, chromatography, UF/DF/TFF, sterile filtration, formulation, DOE, QbD, cGMP compliance, root cause analysis, tech transfer support
Preferred skills
LVV scale-up experience, CDMO tech transfer, PAT/digital tools, next-generation purification technologies
Technologies
Chromatography, UF/DF/TFF, sterile filtration, knowledge management systems
Responsibilities
Plan and perform experiments to develop scalable LVV purification processes; execute and optimize unit operations (clarification, chromatography, UF/DF/TFF, filtration, formulation); design and analyze studies to identify CPPs/CMAs and establish design space; develop scale-down models and support scale-up to pilot/clinical/commercial equipment; evaluate and implement next-generation purification technologies; author protocols and support CMC content for regulatory submissions.
Seniority
Mid-level Scientist (0-2 years PhD or 4-6 years MS)