Associate Director, 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 (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
Lentiviral vector downstream process development, Chromatography, Ultrafiltration/Diafiltration (UF/DF), Sterile filtration, Process characterization, Quality by Design (QbD), Technology transfer, Regulatory CMC documentation, Statistical analysis (DOE), Risk management (FMEA)
Preferred skills
Scaling viral vector processes from preclinical to commercial, Technology transfer to CDMOs, Process Analytical Technology (PAT), Next-generation purification technologies
Technologies
Advanced chromatography, Membrane filtration, PAT/digital tools
Responsibilities
Define and execute end-to-end LVV downstream purification strategies, Lead cross-functional matrixed project teams, Design and qualify scale-down models for process characterization, Author and review CMC documentation and technology transfer packages, Apply QbD principles and risk assessments to define design space, Evaluate novel purification technologies for continuous improvement
Seniority
Senior, hands-on IC with matrix leadership