Director of Drug Substance Operations, Global External Operations

About the role

The Director, Drug Substance Operations is a key leadership role within Global External Operations (GEO), accountable for end-to-end operational oversight of BioMarin’s external drug substance manufacturing network.

Responsibilities

• Provide end to end operational leadership and oversight of CMOs to ensure delivery of reliable, compliant drug substance supply
• Ensure uninterrupted product supply by proactively identifying, escalating, and resolving risks via the GEO tiered escalation framework
• Serve as the primary operational interface for critical CMO issues, ensuring timely resolution and clear communication
• Establish and maintain robust CMO governance frameworks aligned with GEO standards
• Define, monitor, and drive performance against key operational KPIs and scorecards
• Lead performance reviews, identify systemic risks, and implement targeted improvement plans
• Ensure governance requirements, oversight expectations, and site engagement models are consistently applied
• Ensure execution of Operational Readiness Planning (ORP) for new products, tech transfers, and major process changes
• Support successful technology transfers and lifecycle management activities across the network
• Ensure readiness for regulatory inspections and audits through effective operational control and governance
• Develop and execute operational strategies aligned with GEO and enterprise objectives
• Drive value realisation initiatives, including cost optimisation, efficiency improvements, and operational excellence
• Identify and implement process improvements to enhance standardisation, scalability, and cross-functional ways of working
• Lead and develop a high-performing operations team, fostering accountability, capability development, and engagement
• Provide clear direction, coaching, and performance management to ensure delivery of business objectives

Requirements

• Bachelor’s or advanced degree in Science, Engineering, or related discipline
• Significant experience in pharmaceutical or biotech operations, including external manufacturing and CMO management
• Demonstrated leadership experience in a global, matrixed organisation
• Proven track record in delivering operational performance, supply reliability, and continuous improvement
• Strong knowledge of GMP and regulatory expectations

Qualifications

• Experience in leading and managing complex projects and teams
• Knowledge of CMO contract terms and conditions
• Understanding of regulatory requirements and compliance
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team

Skills

• Strategic thinking and planning
• Project management
• Leadership and team management
• Regulatory compliance
• Process improvement and optimization
• Stakeholder management

Benefits

• Comprehensive health insurance
• Flexible work schedule
• Professional development opportunities
• Employee discounts
• Work-life balance programs

Pay

Competitive salary commensurate with experience.

Schedule

Full-time, remote work.