Senior QC Scientist - Program Management
Core
Senior QC Scientist serving as the primary liaison between Quality Control, clients, and external laboratories to ensure testing requirements, timelines, and quality standards are met for GMP manufacturing.
Role type
Senior IC QC Scientist (Program Management)
Builds
GMP-compliant testing processes and deliverables for advanced therapeutic products (AAV, viral vectors, vaccines)
Domain
Biopharmaceutical manufacturing / Gene Therapies
Required skills
GMP regulations, ICH guidelines, FDA requirements, USP/EP standards, project coordination, sample management, stability program coordination, client communication, Microsoft Project, Smartsheet
Preferred skills
Project Management, Contract Manufacturing
Technologies
Microsoft Project, Smartsheet, Microsoft Office Suite
Responsibilities
Serve as primary QC liaison for clients and external labs; Coordinate QC activities across cross-functional teams; Manage internal and external testing execution; Oversee sample, reagent, and material inventories; Establish and coordinate stability programs; Generate and maintain client sampling plans; Develop and maintain project trackers; Align manufacturing schedules with QC testing activities.
Seniority
Senior, hands-on IC
