Associate Principal Scientist, Viral Vector Downstream Process Development
Core
Lead end-to-end lentiviral vector (LVV) downstream purification strategies from early development through commercial manufacturing, ensuring yield, purity, and scalability.
Role type
Associate Principal Scientist, Viral Vector Downstream Process Development
Builds
Scalable, phase-appropriate lentiviral vector purification processes for IND-enabling, clinical, and commercial manufacturing
Domain
Biotechnology / Gene Therapy / Viral Vector Manufacturing
Required skills
Lentiviral vector downstream process development, Chromatography, Ultrafiltration/Diafiltration (UF/DF), Sterile filtration, Process characterization, Design of Experiments (DOE), Quality by Design (QbD), Risk management (FMEA), cGMP compliance, Technology transfer, Regulatory documentation
Preferred skills
Scaling processes from preclinical to commercial, Technology transfer to CDMOs, Process Analytical Technology (PAT), Next-generation purification technologies
Technologies
Advanced chromatography, Membrane filtration, PAT tools, Digital data management systems
Responsibilities
Define and execute LVV purification strategies, Lead cross-functional matrixed project teams, Design and qualify scale-down models, Author CMC documentation and regulatory submissions, Drive root cause investigations and continuous improvement, Evaluate novel purification technologies
Seniority
Senior, hands-on IC with leadership responsibilities