Associate Director, PD Upstream
Core
Leading scientific and operational activities for upstream process development of viral vector production (AAV and LV) to support GMP manufacturing.
Role type
Senior IC Associate Director, upstream process development
Builds
Scalable viral vector production processes for gene therapies
Domain
Biotechnology / Gene Therapy / Viral Vector Manufacturing
Required skills
Mammalian suspension cell culture, transfection, viral production, DOE methodology, statistical data analysis, technology transfer to GMP, team management, project management
Preferred skills
rAAV or lentiviral production platforms, cGMP principles, cross-functional matrixed environment management, senior team member management
Technologies
AAV, LV, cGMP facilities
Responsibilities
Lead day-to-day operations of upstream process development including experimental design and execution; Manage and mentor scientists and research associates; Set technical strategy and ensure regulatory compliance; Author CMC documents and support regulatory filings; Partner with Downstream, Analytical, and Manufacturing teams for process integration; Oversee scalable process development within timelines and budgets; Serve as SME for troubleshooting and optimization.
Seniority
Senior, hands-on IC with leadership responsibilities