Associate Principal Scientist, Viral Vector Downstream Process Development
Core
Lead the development of scalable lentiviral vector (LVV) downstream purification processes from early development through commercial readiness for cell and gene therapy products.
Role type
Associate Principal Scientist (Viral Vector Downstream Process Development)
Builds
Scalable, phase-appropriate LVV purification processes for IND-enabling, clinical, and commercial manufacturing.
Domain
Biopharmaceuticals / Gene and Cell Therapy / Viral Vector Manufacturing
Required skills
LVV downstream process development, chromatography, UF/DF (TFF), sterile filtration, process characterization, DOE, QbD, risk management (FMEA), CMC strategy, regulatory documentation, technology transfer, scale-up modeling, impurity mitigation (HCP, host cell DNA)
Preferred skills
Scaling LVV processes from preclinical to commercial, technology transfer to CDMOs, PAT/digital tools, next-generation purification technologies
Technologies
Advanced chromatography, membranes, PAT tools, digital data management systems
Responsibilities
Define and execute end-to-end LVV purification strategies; lead matrixed project teams and coach scientists; design scale-down models and support scale-up; author CMC documentation and support regulatory submissions; lead process characterization and risk assessments; evaluate novel purification technologies; ensure cGMP compliance and data integrity.
Seniority
Senior, hands-on IC with leadership responsibilities