External Manufacturing Operations Lead

biomarin; United States; On-site; USD 150,000 - 190,000; Full time

Job summary

BioMarin seeks an experienced GEO Operations Manager to oversee external manufacturing at CMOs, covering clinical and commercial products. You will ensure uninterrupted supply and regulatory compliance through cross-functional collaboration.

Responsibilities include coordinating production plans, technology transfers, CAPA/RCA-driven improvements, and GEO performance dashboards, while partnering with SMEs and procurement.

Qualifications

• Minimum requirement of 5 years leadership experience in Operations, Supply Chain or Quality.
• BS/BA degree; life sciences, business, or supply chain management.
• Experience in regulated GXP environments and external manufacturing.

Responsibilities

• Execute with CMOs the production plan to deliver uninterrupted clinical and commercial supply.
• Manage CMO meeting schedules and cross-functional collaboration.
• Identify supply constraints and negotiate with CMOs to meet the plan.
• Lead investigations using CAPA, RCA, and implement corrective actions.
• Coordinate technology transfers and process changes with CMOs.
• Maintain dashboards and metrics to monitor GEO performance.
• Ensure CMO compliance with cGMPs and regulatory requirements.
• Support contracts and negotiations with CMOs alongside procurement.
• Represent GEO in meetings and cross-functional programs.

Skills

Leadership

Cross-functional leadership

Decision making

Initiative

Organizational skills

Stakeholder management

GXP compliance

CAPA/FMEA/RCA

Manufacturing operations knowledge

Communication

Education

BS/BA degree in life sciences or related field

Job description

BioMarin seeks an experienced GEO Operations Manager to oversee external manufacturing at CMOs, covering clinical and commercial products. You will ensure uninterrupted supply and regulatory compliance through cross-functional collaboration.

Responsibilities include coordinating production plans, technology transfers, CAPA/RCA-driven improvements, and GEO performance dashboards, while partnering with SMEs and procurement.