Director of Drug Substance Operations, Global External Operations

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Technical Operations

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

• 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. 
• This role ensures reliable, compliant, and uninterrupted supply of drug substance from Contract Manufacturing Organisations (CMOs) to support clinical and commercial demand. The position drives operational performance through robust governance, KPI‑driven management, and execution of a structured CMO oversight model. 
• The Director partners across Technical Operations, External Quality, Supply Chain, and Technical Development to deliver integrated, risk‑based oversight of external manufacturing while enabling successful product launches, lifecycle management, and network scalability.
• This role combines strategic leadership with hands‑on operational execution, ensuring the GEO organisation maintains an inspection‑ready, high‑performing external manufacturing network aligned with enterprise objectives.

• 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

• Build and maintain strategic relationships with CMO leadership teams to enable issue resolution and long term performance
• Partner with Virtual Plant Teams (VPTs) and cross functional stakeholders to ensure integrated oversight of external operations
• Align internal and external stakeholders on priorities, risks, and execution plans

• 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
• Lead a team of 4-6 professionals across US & Ireland.
• Build organisational capability to support current priorities and future network growth

• 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

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.