Job Description
Astellas offers a stimulating work environment and the opportunity to make a positive impact on society.
We leverage our expertise, science, and technology as a pharmaceutical company, while our open and progressive culture sets us apart as Astellas. This culture is centered around doing good for others and contributing to a sustainable society.
Our driving force is delivering meaningful differences for patients. We have the opportunity to make a difference by working locally in areas where we have expertise, while drawing inspiration from global insights and innovative external partners.
Our global vision for Patient Centricity involves supporting the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity is a guiding principle that drives action. We believe that all staff members have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our daily work practices.
Our ethos is built on the Astellas Way, which comprises five core values: patient focus; ownership; results; openness; and integrity.
We take pride in offering an inclusive and respectful work environment that fosters collaboration and ownership.
Our goal is to bring together top talent, provide them with world-class tools and resources, and create a unique structure that encourages agility and entrepreneurial spirit.
The Opportunity
The QC Biochemist will support operations by completing all required testing, such as product receipt, in-process, finished, and stability testing, as well as report writing, procedure writing, system management, and training. The role will also be responsible for tasks associated with analytical method validation (technical transfer and pharmacopeial method validation).
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.
* 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.
Requirements
* 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 are 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.
Estimated Salary:
€ 60,000 - € 80,000 per annum