Quality Control Lab Operational Readiness

Role: Associate Director of Operational Readiness in QC for Large Molecule Biologics at Wilmington Biotech Campus, focusing on preparing the analytical laboratory for startup and ongoing operations. Responsibilities: lead end-to-end readiness planning, schedule development, cross-functional coordination across QC start-up, sample management, materials, stability, SOPs, training, and inspection prep; establish governance, risk mitigation, and continuous improvement post-launch. Qualifications: Bachelor's in Chemistry, Biochemistry, Engineering or related; 10+ years in QC or regulated biotech/pharma lab operations, with leadership in large-scale startup or capacity expansion. High-Value: biologics, high potent compounds, ADCs, cGMP compliance, analytical method development, validation, release testing, digital lab tools (LIMS, SAP), inspection readiness, and operational excellence. Work setup: On-site Wilmington, with ~5-10% travel.