ASL Scientific Director

2 weeks ago

Dublin Pike, Ireland QCS Staffing Full time

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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