Manager​/Sr. Manager, Analytical Services GXP Laboratory

Who We Are

Bio Marin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options.

More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of Bio Marin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

Bio Marin’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 Bio Marin’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 Manager / Senior Manager, Analytical Services GxP Laboratory provides scientific, technical, and operational leadership for analytical activities supporting commercial products and late-stage development programs. This role is part of the global Analytical Services and Commercial Product Support organization and is responsible for leading a team of scientists and research associates engaged in analytical method transfers, method validation, method troubleshooting, remediation activities, stability studies, investigations, and regulatory support within a cGMP environment.

The Manager / Senior Manager ensures the delivery of high-quality analytical data, regulatory compliance, inspection readiness, and efficient execution of business objectives. This position partners closely with Analytical Product Leads, Quality Control, Manufacturing, Technical Development Services, Quality Assurance, Regulatory Affairs and external laboratories to support product lifecycle management and commercialization activities.

The successful candidate will balance people leadership, scientific oversight, operational excellence, and strategic planning to ensure the Analytical Services organization delivers reliable, compliant, and efficient analytical support across the product portfolio.

This role reports to the Head of Analytical Services and Commercial Product Support in Analytical Sciences.

• Lead, coach, and develop a team of scientists, Senior Research Associates, and Research Associates within the GxP Analytical Services organization and develop a cohesive, balanced, and high functioning team focused on producing high-quality deliverables and outcomes.
• Optimize the organizational design and allocation of team resources to meet the needs of a growing pipeline of products as well as critical non-program strategies and initiatives.
• Establish clear performance expectations, development plans, provide actionable feedback, and chart career growth…