Manufacturing Project Specialist
Core
Lead and manage viral vector manufacturing projects from concept to completion, including technology transfers, capital projects, and campaign support for drug product operations.
Role type
Manufacturing Project Specialist (Viral Vector)
Builds
Viral vector drug products and manufacturing infrastructure
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Viral vector manufacturing processes (50L, 250L, 2KL), technology transfer, batch record procedures, Quality Systems (deviations, change controls, TrackWise), process/equipment validation, project management, GMP compliance
Preferred skills
Drug product operation, filler machine operation, capital project management
Technologies
MS Project, Excel, TrackWise
Responsibilities
Lead viral vector manufacturing projects from concept to completion; drive improvement initiatives for quality, cost, and efficiency; manage CAPAs, deviations, and change controls; collaborate cross-functionally to update policies and procedures; review validation protocols and deviation reports; mentor technicians on new processes; communicate project status and risks to stakeholders.
Seniority
Mid-Senior, hands-on IC