Director, Cold Chain Management & GDP Compliance

Who We Are

Bio Marin 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.

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 coordinate the worldwide movement of our drugs to patients.

Fully remote role, US Candidates

The Director, Cold Chain Management & Supply Chain GDP is a key role as part of the Global Distribution organization. This role is critical to ensuring the integrity of temperature‑sensitive pharmaceutical products throughout the supply chain, while maintaining full compliance with Good Distribution Practice (GDP) regulations and internal quality standards. The incumbent will lead the Global Distribution Center of Excellence for cold chain engineering and Good Distribution Practices supporting distribution (storage and shipping) of all clinical and commercial materials in Bio Marin.

• Lead the design, qualification, and continuous improvement of cold chain systems and packaging solutions for temperature‑sensitive products.
• Oversee monitoring of temperature‑controlled logistics, including refrigerated transport, passive packaging, and storage facilities.
• Collaborate with internal and external stakeholders to ensure robust cold chain solutions across global markets.
• Drive innovation in cold chain technologies and streamlined management and quality of associated data.

• Ensure global compliance with GDP regulations and internal quality standards across all distribution channels.
• Develop and maintain policies, procedures, and training programs related to GDP and supply chain integrity.
• Primary point of contact in Supply Chain for audits and inspections related to distribution and cold chain operations.
• Partner with Quality, Regulatory, and Logistics teams to proactively identify and mitigate compliance risks and bridge operational gaps.

• Direct management of a team of individual contributors across global regions.
• Provide strategic direction and leadership to cross‑functional teams involved in cold chain and compliance activities.
• Advise senior leadership on investment decisions and emerging trends, providing timely risk insights and strategic recommendations that support informed decision‑making.

This role is responsible for supporting the efficient movement of lifesaving therapies in compliance with applicable regulations. Decisions made in this role are of critical nature in mitigating risks for the business while ensuring Bio Marin's commercial products are delivered to patients in a timely and compliant manner.

The candidate should demonstrate the following attributes:

• A firm commitment to Bio Marin's cultural beliefs and values
• Consistent track record of exceeding objectives…