Project Lead QC 80-100%
Core
Lead QC projects for release and stability testing of late-phase and commercial biologics (large molecules and ADCs), serving as the primary QC contact for customers.
Role type
Senior Project Lead, Quality Control (Biologics)
Builds
Release and stability testing protocols and data for late-phase and commercial drug products
Domain
Pharmaceutical manufacturing, Biologics, Large molecules, Antibody Drug Conjugates (ADCs)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP-regulated environment experience, analytical testing of biologics, laboratory capacity assessment, analytical method transfer, analytical testing strategy implementation, cGMP documentation authoring, audit/inspection readiness
Preferred skills
Project coordination, analytical method validation, stakeholder management
Technologies
cGMP documentation systems, analytical testing platforms
Responsibilities
Coordinate QC project activities for release and stability testing; Assess laboratory capacity and manage analytical method transfers; Implement analytical testing strategies including method suitability and specification setting; Author quality records and cGMP documents; Act as QC subject matter expert during audits and customer meetings
Seniority
Senior, hands-on IC
