ASL Scientific Director

4 weeks ago

Dublin, Ireland Quanta Consultancy Services Ltd Full time

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

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