QC Stability Coordinator

Description

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.

QC Stability Coordinator 

Onsite Role (Days)

Shanbally, Ringaskiddy, Co Cork 

Closing Date: 20th Feb 2026

The stability and sample coordinator report directly to the QC Manager and is responsible for

coordinating the movement and storage of product related samples, as well as the coordination of

stability testing in QC.

Key Responsibilities:

• Contribute to selection of intermediate and product lots produced at BioMarin for stability
• studies. 
• Coordinate and contribute to the scheduling of stability testing in QC. Trend stability data and report on same
• Prepare stability related protocols, summaries, and reports - often for direct submission to pharmaceutical regulatory agencies.
• Coordinate movement and storage of samples for testing within QC, within Biomarin and to and from contract laboratories.
• Manage the retention and reserve sample program.
• Act as technical resource (SME) and train other analysts in areas of expertise.
• Review and approve documents such as standard operating procedures, protocols, reports and track-wise documents.
• Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
• Interact indirectly with regulatory agency inspectors during audits.
  Other duties as assigned.

• Minimum 3-5 years relevant industry experience.
• Good project management skills.
• Experience in presenting to senior management.
• Lead from front attitude.
• Knowledge of regulatory guidelines and directives.
• Data orientated with good risk management understanding.

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.