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.

Senior Manager, Analytical Services

Onsite Role - Shanbally, Ringaskiddy, Cork

Closing Date:

Job Summary

The Senior Manager, Analytical Services is a leadership position in the Analytical Sciences team, focused on leading a team of Scientists, Research Associates and Analysts who provide GxP, Non-GxP, & Method Establishment attribute phase appropriate testing support for internal and external programs. The Senior Manager/Manager is also accountable for maintaining an inspection ready laboratory.

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.

Senior Manager, Analytical Services

Job Description