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ASL Scientific Director
Employer undisclosedRole managed by a recruiter
Lead analytical CMC strategy for late-stage biologics commercialization
9d ago
Expert & Leadership (13+ years), Experienced (8-12 years)
Contractor
Dublin, County Dublin, Ireland
Hybrid
Role
What you would be doing
scientific oversight
cmc strategy
regulatory docs
method validation
tech transfer
lifecycle management
- Provide scientific oversight for commercial product lifecycle management—specifications, method lifecycle, reference standards, and comparability.
- 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.
- 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 bring
communication
technical writing
analytical cmc
regulatory standards
leadership
phd
- Strong communication and technical writing skills, capable of translating complex science into clear regulatory language.
- Extensive expertise in analytical CMC for biologics, including specification setting, comparability strategy, method lifecycle, and reference standards.
- Deep understanding of analytical methods and global regulatory standards, with experience supporting inspections and compliance.
- Proven ability to author complex regulatory documents and contribute strategically to global submissions and health authority interactions.
- Effective cross-functional leadership, influencing matrix teams and driving alignment without direct authority.
- A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with extensive biologics experience within analytical CMC / relevant field, respectively.
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Interview process
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Your recruiter
Your recruiting firm
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- Experience in delivering recruitment services for large infrastructure and energy projects.
- Specializes in sourcing skilled professionals for both permanent and temporary roles.
- Recognized for working on complex and large-scale projects with a diverse client base.
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