ASL Scientific Director

Posted 7 days 18 hours ago by Quanta Consultancy Services Ltd

125 000,00 € - 150 000,00 € Annual
Permanent
Full Time
Other
Dublin, Dublin, Ireland
Job Description
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 there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.

What you'll do
  • 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.
What you'll need
  • A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with extensive biologics experience within analytical CMC / relevant field, respectively.
  • 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!