QC Director, Lab Instrumentation, Digital Systems & Connectivity
Core
Senior technical leader responsible for end-to-end design, start-up, and sustained operation of laboratory instrumentation, digital systems, and enterprise connectivity platforms for a new biotech manufacturing facility.
Role type
Senior Director, Laboratory Instrumentation & Digital Systems
Builds
A fully connected, digitally enabled, paperless Quality Control laboratory for high-potent biologics and ADCs.
Domain
Biotechnology / Pharmaceutical Manufacturing / Analytical Chemistry
Deliverable
Production ML models | infrastructure | dashboards & analysis
Required skills
Laboratory instrumentation strategy, CQV (Commissioning, Qualification, Validation), LIMS/CDS/ELN integration, GxP compliance, new facility start-up, data integrity (ALCOA+, 21 CFR Part 11), cross-functional leadership
Preferred skills
Advanced analytics, AI/automation in lab operations, high-potent compound containment, predictive maintenance
Technologies
LIMS, CDS (Empower), ELN, Enterprise data lakes, HPLC/UPLC, Mass Spectrometry
Responsibilities
Lead design and specification of laboratory infrastructure and digital systems; execute integrated start-up master plan and CQV strategy; manage instrumentation lifecycle including procurement, maintenance, and calibration; serve as SME during health authority inspections; drive adoption of automation and advanced analytics for lab optimization.
Seniority
Senior, hands-on IC with strategic leadership
