Operations Manager, Global External Operations

Role: GEO Operations Manager overseeing external manufacturing operations at Contract Manufacturing Organizations (CMOs) for both clinical and commercial biologics and small molecules. Primary objectives include ensuring continuous supply, operational readiness, and regulatory compliance. Responsibilities encompass managing day-to-day CMO activities, executing production plans, resolving supply constraints, monitoring manufacturing processes, and supporting technology transfers and change management. The role acts as the main communication conduit between BioMarin and CMOs, leads process and product launches, and supports quality and compliance standards.

Qualifications: Minimum 5 years of leadership experience in Operations, Supply Chain, or Quality within a regulated GxP environment; BS/BA in life sciences, business, or supply chain management. Skills required include strong understanding of manufacturing processes, cross-functional team leadership, decision-making, stakeholder management, and proficiency with CAPA, FMEA, RCA tools. Excellent organizational, communication, and commercial acumen are essential.

High-Value: Focus on biologics and small molecules, supporting clinical and commercial supply, with involvement in process change evaluation, technology transfer, validation, and compliance activities. Experience with supply planning, inventory management, and managing external manufacturing partners is preferred.