ASL Scientific Director
- Ireland, Dublin
- Contract
- Life Sciences
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.
- 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.
#LI-JS4
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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James
I manage this role.