Chief Analytical Officer
2 days ago
Company Overview
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.
We have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
We develop medicines for patients with significant unmet medical need by enlisting the best technical experts and creating an environment that empowers teams to pursue innovative science.
About Technical Operations
BioMarin's Technical Operations group is responsible for creating drugs for clinical trials and scaling production for the commercial market.
The team builds and maintains cutting-edge manufacturing processes and sites, provides quality assurance and control, and procures goods and services to support manufacturing and drug distribution.
Job Description
The Chief Analytical Officer leads BioMarin's end-to-end Analytical Sciences organization, providing strategic and technical direction across the entire product lifecycle.
This role oversees analytical control strategies, technical development, method transfers, characterization, and technical stewardship for both clinical pipeline and commercial products.
Key Responsibilities
Leading the analytical teams supporting technical stewardshipDeveloping consistent analytical models encompassing support for drug substance and drug product across all phases of product development and lifecycle managementEnsuring delivery of technologies and analytical methods that support the pipeline, including troubleshooting in laboratoriesDeveloping and implementing strategy to sustain robust analytical technical support of QC LabsCollaborating 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 inspections-
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