Our client is a leading manufacturing organisation with a state‑of‑the‑art facility based in Tullamore.
Known for its investment in innovation and technology, the site offers a dynamic and technically challenging environment.
This is an excellent opportunity to join an established company that is committed to excellence and offers a strong culture of teamwork and professional development.
In this role, you will act as a technical expert, supporting projects such as analytical method transfer exercises (AMTE), method development, and validation for biopharmaceutical products from initial concept through to regulatory submission.
Responsibilities Supporting analytical method transfer exercises (AMTE) to and from the site.
Developing, optimising, and validating analytical test methods for in‑process and final product testing.
Supporting technical investigations of analytical methods associated with recombinant antibodies.
Authoring technical documents, including test methods, SOPs, training material, protocols, and reports.
Troubleshooting complex analytical methods and supporting investigations in QC and GMT.
Authoring and supporting deviations, change controls, validation events, and system suitability failures.
Operating, monitoring, and maintaining technical equipment to ensure optimal performance.
Supporting regulatory submissions and responding to technical questions from regulators.
Collaborating with external contract testing service providers and global technical teams.
Assisting with regulatory inspections and internal audits to ensure documentation meets GMP and GDP standards.
Experience BSc or MSc in a relevant discipline (e.g., biochemistry, protein chemistry, analytical chemistry) or equivalent experience.2+ years' relevant experience in laboratory analysis (QC or bio‑analytical) using methods such as LC, CE‑SDS, ELISA, or glycan analysis.
Strong technical writing skills to support reports, protocols, test methods, and SOPs.
Working knowledge of operating in a GMP environment.
Proficiency in a range of analytical methods (p H, protein concentration, ELISA, LC‑based methods, CE‑SDS, c IEF).
Excellent interpersonal, verbal, and written communication skills.
Logical troubleshooting and problem‑solving skills with a strong detail‑oriented approach.
Self‑motivated and adaptable to a fast‑paced environment with changing priorities.
Ability to learn quickly and take full responsibility for technical tasks and projects.
To discover more about this opportunity please apply online or contact Lewis Murray on +353 87 204 3307 for a confidential discussion.
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