GEO Operations Specialist

BioMarin Global External Operations Specialist

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists, and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Cork, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.

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 Global External Operations (GEO) 'virtual' site works directly with contract manufacturing organizations (CMO's) globally to produce BioMarin products. The GEO site is experiencing significant growth in 2026. The GEO Operations Specialist role will serve as an integral member of the GEO Operations team. This role will specifically support biologics and small molecule drug product processing as well as finished goods packaging. Clinical and commercial products are within the scope of the role.

The candidate will directly support the GEO Operations Managers/Process Team Leads who are responsible for ensuring seamless supply of product(s) from the contract manufacturing organizations (CMO). The candidate may also need to work independently on specific activities, e.g. operational readiness execution for new product/processes. The GEO Operations Specialist role will report to the Director of Operations, GEO.

Key Responsibilities

• Execute operational readiness requirements to enable CMO's to produce BioMarin products.
• Provide direct support to Process Team Leads across Commercial & Clinical products (Small Molecules, Biologicals, Drug Product and Packaging operations on targeted/prioritized activities).
• Manage and execute all transactional ERP aspects at BioMarin for production efforts at CMOs (includes executing production transactions, updating work order dates, receipting of purchase orders, inter organizational transfers etc.)
• Own and manage prioritized change controls and deviations within the Biomarin Quality Management System (QMS) to effective on time closure and no impact on supply.
• Consolidation and issuance of key performance metrics per Process Team.
• Provide back-up support for Process Team Leads where necessary (e.g. holidays)
• Support selected continuous improvement activities aligned to the site business plan objectives with clear and measurable time and money savings.
• Work cross-functionally to perform rigorous root cause analysis, to understand issues and implement corrective actions as appropriate.
• Document key business processes in a standard format (e.g., Best Practice Document or Standard Operating Procedure).
• There may be a need for this person to execute operational tasks with a view to eliminating or reducing the number of touchpoints associated with a task.
• This list of support responsibilities may change depending on business needs and employees are expected to be adaptable and flexible where this need arises.

Experience & Skills:

• Minimum requirement of 7 years' experience within an Operations and regulated environment.
• Relevant 3^rd level qualification.
• Will have a good working understanding of the processes/unit operations for biological drug product and/or finished goods packaging.
• Ability to project manage multiple activities/complex project(s).
• Technological savviness (e.g. power BI)
• Will have a working understanding of ERP systems (e.g. SAP)
• Ability to engage cross functional teams in the resolution of short-term issues and sustained performance for long-term goals.
• Experience in lean/six sigma/continuous improvement tools and techniques.
• Excellent written and verbal communication skills.
• A high level of initiative and drive, as well as excellent organizational skills, are key role requirements.
• Ability to work independently.

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.