Director of Drug Substance Operations, Global External Operations
BioMarin Pharmaceutical Inc.
June 24, 2026
Remote friendly (United States)
United States
$174,400 - $239,800 USD yearly
Operations
Summary:
- Provide end-to-end operational oversight of BioMarin’s external drug substance manufacturing network (CMOs).
- Ensure reliable, compliant, uninterrupted drug substance supply to support clinical and commercial demand.
- Drive operational performance through governance and KPI-driven management using a structured CMO oversight model.
- Partner across Technical Operations, External Quality, Supply Chain, and Technical Development for integrated, risk-based external manufacturing oversight and support product launches, lifecycle management, and network scalability.
Responsibilities:
- Provide end-to-end operational leadership and oversight of CMOs to ensure reliable, compliant drug substance supply.
- Proactively identify, escalate, and resolve supply risks via the GEO tiered escalation framework.
- Serve as primary operational interface for critical CMO issues; ensure timely resolution and clear communication.
- Establish and maintain CMO governance frameworks aligned with GEO standards.
- Define/monitor KPIs and scorecards; lead performance reviews and implement improvement plans.
- Build strategic relationships with CMO leadership teams; partner with Virtual Plant Teams (VPTs) and cross-functional stakeholders.
- Execute Operational Readiness Planning (ORP) for new products, tech transfers, and major process changes; support regulatory inspection readiness.
- Develop and execute operational strategy; drive value realization (cost/efficiency/operational excellence) and process improvements.
- Lead and develop an operations team (4–6 professionals across US & Ireland).
Qualifications:
- Bachelor’s or advanced degree in Science, Engineering, or related discipline.
- Significant experience in pharmaceutical/biotech operations, including external manufacturing and CMO management.
- Demonstrated leadership in a global, matrixed organization.
- Proven track record in operational performance, supply reliability, and continuous improvement.
- Strong knowledge of GMP and regulatory expectations.
- Provide end-to-end operational oversight of BioMarin’s external drug substance manufacturing network (CMOs).
- Ensure reliable, compliant, uninterrupted drug substance supply to support clinical and commercial demand.
- Drive operational performance through governance and KPI-driven management using a structured CMO oversight model.
- Partner across Technical Operations, External Quality, Supply Chain, and Technical Development for integrated, risk-based external manufacturing oversight and support product launches, lifecycle management, and network scalability.
Responsibilities:
- Provide end-to-end operational leadership and oversight of CMOs to ensure reliable, compliant drug substance supply.
- Proactively identify, escalate, and resolve supply risks via the GEO tiered escalation framework.
- Serve as primary operational interface for critical CMO issues; ensure timely resolution and clear communication.
- Establish and maintain CMO governance frameworks aligned with GEO standards.
- Define/monitor KPIs and scorecards; lead performance reviews and implement improvement plans.
- Build strategic relationships with CMO leadership teams; partner with Virtual Plant Teams (VPTs) and cross-functional stakeholders.
- Execute Operational Readiness Planning (ORP) for new products, tech transfers, and major process changes; support regulatory inspection readiness.
- Develop and execute operational strategy; drive value realization (cost/efficiency/operational excellence) and process improvements.
- Lead and develop an operations team (4–6 professionals across US & Ireland).
Qualifications:
- Bachelor’s or advanced degree in Science, Engineering, or related discipline.
- Significant experience in pharmaceutical/biotech operations, including external manufacturing and CMO management.
- Demonstrated leadership in a global, matrixed organization.
- Proven track record in operational performance, supply reliability, and continuous improvement.
- Strong knowledge of GMP and regulatory expectations.