Senior Engineer, Drug Product
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 develop medicines for patients with significant unmet medical need. Our Technical Operations group creates our drugs for use in clinical trials and scales production for the commercial market.
This role supports filling operations, working in a matrix team environment to achieve project objectives. Key responsibilities include technical risk assessments, process comparisons, and deviation resolution.
* Technical SME for drug product (DP) supporting filling operations.
* Develop process comparisons and manage DP technical and manufacturing risks.
* Author technical reports to support DP process and product characterisation.
* Manage change control, deviations, and CAPAs through the quality management system.
A strong understanding of MSAT, process development, or technology transfer, with a background in large-scale processing of biologic drug products is required. Excellent organizational, interpersonal communication, and problem-solving skills are essential.
This is an exciting opportunity to join BioMarin's Technical Operations group in Shanbally, Ireland.