QC Specialist
Core
Lead Quality Control operations for a CDMO specializing in parenteral lipid nanoparticle drug formulations, managing schedules, resources, and testing activities from raw material to release.
Role type
Senior QC Operations Lead / Project Manager
Builds
Liposomal drug products and complex delivery-based formulations for biotechnology and pharmaceutical clients
Domain
Pharmaceutical manufacturing / CDMO / Parenteral drug delivery
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Control operations, project management, resource planning, stability testing management, reference standard management, regulatory compliance (GxP), operational planning, data accuracy, technical writing
Preferred skills
CDMO environment experience, LEAN processes, Six Sigma, cross-functional collaboration
Technologies
LEAN, Six Sigma
Responsibilities
Prioritize QC work to meet business needs, optimize QC schedules and operational activities, manage QC master schedules and resource allocation, draft drug product specifications and sampling plans, manage stability projects and inventory, perform peer review of QC data, coordinate reference standard purchasing and management
Seniority
Senior, hands-on IC with leadership responsibilities