Lead GMP Technician, Downstream (2nd Shift)
Core
Lead downstream GMP manufacturing operations for viral vector purification in gene therapy.
Role type
Lead GMP Manufacturing Technician (Downstream)
Builds
Viral vector products for gene therapy patients
Domain
Biotechnology / Gene Therapy / cGMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Downstream GMP manufacturing, Column packing/testing, Tangential flow filtration (TFF), Affinity/Anion exchange chromatography, Chromatography, Filtration, Centrifugation, Equipment operation and troubleshooting, cGMP regulations, Biological drug development, Mathematical calculations for buffer preparation and dilution
Preferred skills
Aseptic techniques, Automated systems, Gene therapy manufacturing, Single-use technologies
Technologies
TFF, Chromatography systems, Centrifuges
Responsibilities
Lead downstream operations for viral vector purification, Plan and manage downstream activities and process optimization, Demonstrate proficiency on specific downstream equipment, Complete and review manufacturing documentation, Collaborate with MS&T for process transfer, Compile data and analyze results for client summaries, Collaborate with Quality Systems to satisfy GMP regulations, Train and mentor junior technicians, Report unexpected issues and implement CAPA, Partner with Technical Writing for GMP documentation
Seniority
Senior, hands-on IC with team leadership