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.

Sr. Manager/Manager, Analytical Services

Onsite Role - Shanbally, Ringaskiddy, Cork

Closing Date:  30th September 2025

Job Summary

Key Responsibilities: 

• Department Leadership and Management
• Collaborate with AS Functional Head and People Department to identify needs and participate in recruiting, hiring
• Lead and develop a cohesive, balanced, and high functioning team focused on producing high quality deliverables and outcomes
• Provide support to the team through excellent change management skills
• Optimize the organizational design and allocation of team resources across the Technical Lab Operations to meet the needs of a growing pipeline of products as well as critical non-program strategies and initiatives
• Mentor, coach and inspire Analytical Services team on BioMarin skill and career development
• Ensure all individual training and guidelines are kept current.
• Set short- and long-term Analytical Services department goals oriented to a high performing Analytical Services function (e.g., Objectives and Key Results (OKRs))
• Manage annual budget, operational expenditures, and forecasting activities
• Delegate responsibilities of laboratory equipment qualification and maintenance, where applicable
• Review protocols, experimental designs to support clear instructions for implementation and execution of experiments
• Support analytical design of special studies for product development activities
• Provide technical expertise for analytical methods and  analysis of trends for data
• Review and approve documents such as, but not limited to, standard operating procedures, protocols, reports and QMS records
• Collaboratively lead the strategic expansion of laboratory capabilities including drug product forensics capabilities.
• Provide technical support to Manufacturing, Quality and QC during manufacturing and/or investigations, when required  

Regulatory and Compliance:

• Ensure the laboratory in an inspection-ready state and that all Analytical Services staff take part in maintaining the lab in an inspection ready state
• Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives when needed
• Ensure the team is compliant to safety and environmental standards 

Process Improvement & Training:

• Support the implementation and management of GxP, Non-GxP, & Method and phase-appropriate testing within Analytical Services
• Support improvement activities to ensure delivery of scientifically sound and analytical methods
• Support or lead continuous improvement in procedures and systems to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH) 

Skills & Experience:

• Process Development and/or Manufacturing science experience preferred
• Experience in process analytics  as part of process development work 
• Experience leading teams through organizational change
• Expertise in biochemical techniques such as enzymatic activity, enzyme kinetics, and cell-based method.
• Expertise in separations methods
• Excellent people development skills and team leadership
• Excellent communication and stakeholder management skills
• Organizational skills and aptitude for developing robust processes to improve efficiency in the labs
• Experience supporting CMC teams preferred

Education:

• B.S +10 years experience, MSc + 8 years experience, or PhD + 3-5 years experience  

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.