GEO Operations Specialist

Who We Are

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.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

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 GEO Operations Support role will serve as an integral member of the Global External Manufacturing Operations team who have responsibility for and play a key role in supporting external contract manufacturing activities relating to commercial & clinical drug products.

He/She 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). This candidate will be required to work across a number of multi-modality process teams to manage and execute ERP, QMS transactional activities as well as other support tasks. The GEO Operations Support role will report to the Director of Operations, GEO.

Key Responsibilities

- Provide direct support to Process Team Leads across Commercial & Clinical products (Small Molecules, Biologicals, Drug Substance, 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 operation 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 5 years’ experience within an Operations and regulated environment.

Relevant 3rd level qualification.

Required skills needed to accomplish the responsibilities/essential functions include:

- Will have a working understanding of ERP systems (e.g. SAP)

- Will have a good working understanding of the processes/unit operations assigned to the team.

- 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.

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