Director, External Capabilities, Analytical Capabilities and Operations (ACO)

Leadership role within pharmaceutical development sciences overseeing externalized analytical capabilities for large molecule programs. The director will manage a team of scientists, drive externalization strategy execution, and ensure analytical quality and compliance across clinical supply and commercialization stages.

Responsibilities

• Execute externalization strategy and optimize operating model aligned with enterprise goals
• Oversee analytical deliverables and quality control for drug substance and product at external partners
• Lead capability building at strategic partners through upskilling and knowledge transfer
• Manage analytical method transfers to commercial QC laboratories for regulatory submissions
• Ensure compliant documentation standards and high-quality deliverables from external network

Requirements

• Ph.D. with 8+ years experience, or Master's with 10+ years, or Bachelor's with 15+ years
• Strong knowledge of biologics CMC landscape, GMP regulations, and health authority guidelines
• Experience with diverse analytical methods including microbiological, potency, biochemical, and biophysical characterization
• Project management expertise with resource allocation, budgeting, and risk mitigation capabilities
• Track record moving pipeline assets through development-to-commercialization interface
• Demonstrated ability to lead cross-functional teams and manage external partner relationships
• Critical thinking skills for complex scientific data interpretation and decision-making