QC Biochemist

QC Biochemist About Astellas : At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges putting the patient at the heart of every move we make. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked. We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients' lives. From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners. The opportunity : The QC Biochemist will be responsible for supporting operations through completion of all testing required e.g., receipt, in-process, finished and stability product testing, report writing, writing procedures, management of systems and training. The role will also have responsibility for tasks associated with analytical method validation (technical transfer and pharmacopeial method validation). Key Responsibilities : Perform tasks in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), ensuring safety compliance in the laboratory and facility. 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. Essential Knowledge & Experience : 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. 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 are 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. #LI-Tralee #LI-Onsite #LI-LG1 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login / Register.