Senior Director, CMC & Lab Specialization
Core
Lead the modernization of legacy laboratory and CMC systems to create a tech-enabled environment for AI-driven insights in vaccine and biologics development.
Role type
Senior Director, CMC & Lab Specialization
Builds
Future-ready lab data solutions and standardized scientific workflows
Domain
Biopharma, CMC, Laboratory Operations, Vaccine Development
Deliverable
production ML models | product features
Required skills
CMC process development, laboratory operations, regulatory compliance (GMP), team leadership, stakeholder management, process scale-up, manufacturing systems knowledge
Preferred skills
Lab informatics (LIMS), manufacturing execution systems, AI/ML integration in lab workflows, global harmonization programs, vendor contract management, risk-based validation (GAMP)
Technologies
DevSecOps, automated testing, observability, AI/ML, LIMS, MES
Responsibilities
Define and execute a 3–5 year vision for lab and data transformation, embed modern practices like DevSecOps and AI/ML, manage complex application landscapes, partner with R&D and Tech teams to simplify systems, promote data standardization, build and mentor high-performing teams
Seniority
Senior Director, strategic leadership with hands-on technical oversight