Director of Drug Substance Operations – Global External Operations

🕒 June 25

🏄 California – Remote

🏄 California – Remote

⏰ Full Time

🔴 Lead

⚙️ Operations

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BioMarin Pharmaceutical Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 Post-IPO Debt on 2020-05

Healthcare • Biotechnology • Pharmaceuticals

BioMarin Pharmaceutical Inc. is a leading global biotechnology company dedicated to transforming genetic discoveries into innovative medicines. Founded in 1997, the company has developed eight marketed products that address life-threatening genetic and lysosomal storage disorders such as achondroplasia and severe hemophilia A. BioMarin is also heavily invested in research and development, with a robust pipeline of investigational medicines at various clinical trial stages. The company's mission revolves around improving patient care by leveraging scientific expertise to understand the underlying causes of these conditions. BioMarin is committed to inclusivity and patient advocacy, engaging closely with communities to enhance care and quality of life for those with rare conditions.

📋 Description

• 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 • Build and maintain strategic relationships with CMO leadership teams to enable issue resolution and long term performance • Develop and execute operational strategies aligned with GEO and enterprise objectives • Lead and develop a high performing operations team, fostering accountability, capability development, and engagement

🎯 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

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development