Overview
ASL Scientific Director - Ireland, Dublin - 12 Month Contract
One of the top 10 best companies to work in Ireland is looking for an ASL Scientific Director for their large-scale new facility in Dublin. Is this you? An exciting project with opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This client offers the opportunity to work within a large-scale environment with cutting edge technology.
Responsibilities
* Lead analytical CMC strategy for late-stage assets moving toward commercialisation.
* Author and review key regulatory documents, including JOS, comparability protocols, briefing documents, and health authority responses.
* Provide scientific oversight for commercial product lifecycle management—specifications, method lifecycle, reference standards, and comparability.
* Act as a subject matter expert, guiding cross-functional teams and ensuring regulatory alignment.
* Drive execution and troubleshooting, offering leadership in method updates, validations, tech transfers, and ensuring high-quality deliverables.
Qualifications
* A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with extensive biologics experience within analytical CMC / relevant field.
* Extensive expertise in analytical CMC for biologics, including specification setting, comparability strategy, method lifecycle, and reference standards.
* Proven ability to author complex regulatory documents and contribute strategically to global submissions and health authority interactions.
* Strong communication and technical writing skills, capable of translating complex science into clear regulatory language.
* Effective cross-functional leadership, influencing matrix teams and driving alignment without direct authority.
* Deep understanding of analytical methods and global regulatory standards, with experience supporting inspections and compliance.
If this role is of interest, please apply now!
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