Biologics Process Expert
6 days ago
BioMarin'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. 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.
Job SummaryWe are seeking a Senior Scientist, Technical Development to join our team in Cork, Ireland. As a Senior Scientist, Technical Development, you will be responsible for providing technical oversight of a portfolio of biologic Drug Products at external Contract Manufacturing Organizations (CMOs) and internal sites.
Key Responsibilities- Ensure that Drug Product manufacturing processes perform as developed and validated while ensuring continuous process improvement through the application of scientific and engineering expertise.
- Drive technical requirement for pipeline products assisting late phase and PPQ campaign activities between Technical Development group and External Manufacturing network.
- Ensure readiness of processes for commercialisation.
- A minimum of 5 years' relevant experience in the biopharmaceutical industry with a strong MSAT and process development experience in Drug Product biologics.
- Working knowledge of pharmaceutical regulatory requirements appropriate to level and strong knowledge of the cGMP manufacturing process.
- Ability to collaborate in a global team environment at all levels of the organisation.
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