GMP Technician I, Downstream
Core
Perform routine downstream manufacturing operations for AAV-based gene therapy products in compliance with cGMP regulations.
Role type
Technician I, GMP Manufacturing (Downstream)
Builds
AAV-based gene therapy products
Domain
Biotechnology / Gene Therapy
Required skills
chromatography, filtration, ultrafiltration/diafiltration, TFF systems, process validation, in-process testing, cGMP compliance, SOP adherence, cleanroom gowning
Preferred skills
cGMP manufacturing experience, downstream processing, biologics manufacturing, viral vector gene therapy principles
Technologies
chromatography systems, filtration systems, centrifuges, TFF systems
Responsibilities
Perform routine downstream manufacturing operations including chromatography, filtration, and viral vector formulation; Prepare and operate equipment ensuring proper calibration; Monitor critical process parameters and report deviations; Execute in-process testing and quality control checks; Assist in process validation and technology transfer activities.
Seniority
Entry-level Technician