At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
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 work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
The QC Microbiologist will be responsible for supporting operations through completion of all testing required e.g., environmental monitoring of graded areas and clean utilities, product testing, report writing, writing procedures, and training. Your role will also have responsibility for tasks associated with analytical method validation (technical transfer and pharmacopeial method validation).
Key Responsibilities:
- Ensure compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) in all tasks, including safety protocols.
- Oversee analytical technical transfers and qualification of Pharmacopeial methods for the laboratory.
- Manage environmental monitoring programs, product testing, trend reports, and related activities.
- Lead microbial testing training, troubleshoot instruments, and handle procedure/report writing.
- Author and update laboratory processes, manage incident reports, non-conformances, and CAPAs.
- Support cleanroom and aseptic process qualifications, participate in QC process improvement, and represent QC in cross-functional meetings.
Essential Knowledge & Experience:
- Strong knowledge of Laboratory Information Management Systems (LIMS), SAP, Empower, and TrackWise.
- Extensive experience with instrumentation, including icIEF, Capillary Electrophoresis, Liquid Chromatography (ELS, TUV, FLR detectors), Polarimetry, and Moisture content analysis.
- Proficient in completing Pharmacopeial testing with a solid understanding of relevant standards.
Education:
- B.S. degree in Microbiology with relevant industry experience in a Pharmaceutical Quality Control lab.
Additional information:
- This is a permanent full-time position.
- This 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.
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