Analytical Method Specialist
2 days ago
At CPL, we are seeking an experienced Analytical Method Specialist to join our team at our state-of-the-art site in Dublin, Grange Castle. This is a fixed-term contract role with hybrid working arrangements.
About the Role:
- Manage external analytical method transfer and new product introduction projects, including mRNA products for rest of world markets and new emerging markets/localisation projects.
- Liaise with customers, both internal and external, to support overall method transfer processes.
- Provide technical support for all new country launches.
- Author, review, and critique analytical/regulatory leaflets for new filing applications for established and new products, including mRNA products.
Required Skills and Qualifications:
- B.Sc. degree in biological/chemical sciences, business, or related technical field.
- Minimum 4-6 years' experience in QA/QC GMP environment in pharma/biotech company.
- Experience with technical elements of analytical method validation and transfer process.
- Proven knowledge in analytical techniques, instrumentation theory and practice.
About You:
To be successful in this role, you will require excellent communication and interpersonal skills, proven project management abilities, and experience working with regulatory submission processes and queries.
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