Director, External Capabilities, Analytical Capabilities and Operations (ACO)
Core
Lead a group of scientists supporting externalized analytical deliverables for large molecule programs, driving externalization strategy and operational excellence.
Role type
Director, External Capabilities and Operations
Builds
External analytical network for Biologics, ADC, and Vaccine programs
Domain
Pharmaceutical Analysis, Large Molecule CMC, GMP
Required skills
People Leadership, Analytical Method Development, Regulatory Compliance, Biologics CMC, Project Management, Quality Control, Strategic Partner Management, Data Interpretation, Pipeline Development, Commercialization
Preferred skills
Negotiation, Risk Assessment, Budget Forecasting, Resource Management, Cross-functional Collaboration
Technologies
Chromatographic Techniques, Microbiological Assays, Potency Assays, Biophysical Characterization, GMP Systems
Responsibilities
Execute externalization strategy and optimize operating model; Oversee analytical deliverables and QC for external partners; Manage transfer of methods to commercial QC labs; Ensure high-quality documentation and compliance from external partners; Develop talent and drive scientific excellence within the team; Optimize operating model with ACO leadership.
Seniority
Director, strategic leadership & team management
