Astellas offers an inspiring workplace and the chance to make a positive impact on people's lives.
Our Culture
We're a pharma company driven by science, technology, and a commitment to doing good for others. Our open and progressive culture is what sets us apart. It's a culture of contributing to a sustainable society and making a meaningful difference in patients' lives.
Patient Centricity
We believe that every staff member plays a crucial role in creating a patient-centric culture. This guiding principle shapes our actions and informs our everyday working practices. We strive to understand the patient experience and develop innovative health solutions that meet their needs.
The Astellas Way
Our ethos is built on five core values: patient focus, ownership, results, openness, and integrity. These values underpin everything we do and guide our decision-making.
Inclusive Work Environment
We're proud to offer an inclusive and respectful work environment that fosters collaboration and ownership. Our goal is to bring together talented individuals who share our values and passion for making a difference.
The Opportunity
We're seeking a QC (Quality Control) Biochemist to support our operations. The successful candidate will be responsible for completing testing tasks, including receipt, in-process, finished, and stability product testing. They'll also oversee analytical method validation and manage laboratory systems.
Responsibilities
* Perform tasks in accordance with 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 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.
Education
* B.S. degree in Chemistry/Microbiology with relevant industry experience in a Quality Control lab or equivalent.
Additional Information
* This is a permanent, full-time position.
* Position is based in Tralee – Ireland.
* This position requires you to be 100% on-site/in the office.
We're an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.