Astellas is an inspiring place to work, making a positive impact on people's lives.
We leverage our expertise in science and technology to deliver meaningful differences for patients.
Our Patient Centricity approach prioritizes understanding the patient experience to develop innovative health solutions.
The Opportunity
The QC Biochemist role supports operations by completing testing, reporting, and procedure writing, while ensuring compliance with GLP and GMP.
This involves managing technical transfers, method validation, laboratory instrumentation qualification, product testing, trend reports, and training personnel.
The ideal candidate will have extensive experience with instrumentation, LIMS, SAP, and analytical technologies, as well as a solid understanding of Pharmacopeial testing.
This is a permanent, full-time position based in Tralee, Ireland, requiring 100% on-site presence.
Responsibilities:
* Perform tasks according to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
* Manage analytical technical transfers, qualification of Pharmacopeial methods, and laboratory instrumentation qualifications.
* Oversee product testing, trend reports, and all associated activities; troubleshoot instruments and write reports/procedures.
* Train personnel on biochemical testing processes and document results in LIMS, ensuring peer review.
* Handle incident reports, non-conformances, CAPAs, OOS investigations, and lead QC process improvement projects.
* Author and update laboratory policies, procedures, and data trending, including Continuous Process Verification.
* Proficient in laboratory technologies including LIMS, SAP, Empower, and TrackWise.
* Extensive experience with instrumentation such as icIEF, Capillary Electrophoresis, Liquid Chromatography (ELS, TUV, FLR detectors), Polarimetry, and Moisture content analysis.
* Solid understanding and experience in completing Pharmacopeial testing.
To be successful, you should have a B.S. degree in Chemistry/Microbiology with relevant industry experience in a Quality Control lab or equivalent.
Astellas is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.