Director of Product Lifecycle

3 days ago


Dublin, Dublin City, Ireland Biomarin Full time

About Our Team

BioMarin's Technical Operations group is a dynamic team of experts responsible for creating drugs for clinical trials and scaling production for the commercial market.

We build and maintain cutting-edge manufacturing processes and sites, provide quality assurance and control, and procure goods and services to support manufacturing and drug distribution.

About the Job

The Director of Product Lifecycle will lead BioMarin's Analytical Sciences organization, providing strategic and technical direction across the entire product lifecycle.

This role will oversee analytical control strategies, technical development, method transfers, characterization, and technical stewardship for both clinical pipeline and commercial products.

Key Responsibilities

Collaborating with Drug Product, Substance, Quality, and Regulatory functions to ensure alignment of business processes and technology related to laboratory operationsDrafting and approving CMC sections in regulatory filings and supporting agency interactions and inspectionsEngaging in the external environment related to analytical characterization, method development, scientific advancements, and new modalities

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