Senior QC Microbiology Analyst

Job Description

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Job Description QC Microbiology Analyst Are you looking for a patient-oriented, innovation-driven company that inspires you and promotes your career? Then take your future in your hands and become part of Takeda as a Experienced QC Microbiology Analyst. Takeda's presence in Ireland was established in 1997 and our Irish operations have played an important role in our global leadership in rare diseases, oncology and gastroenterology. Since beginning commercial operations, Takeda Ireland has grown in strength thanks to substantial investment in our people and industry-leading technology.

How you will contribute:

• Responsible for oversight of the Microbiology laboratory supporting the manufacture of Cell therapy product.
• Oversee aseptic practices (gowning, monitoring, cleaning, and related training).
• Perform microbiological testing to support operations.
• Perform environmental monitoring to support operations.
• Ensure that the Microbiology laboratory is set up and operates in compliance with current Good Laboratory Practice / Good Manufacturing Practice.
• Maintain standards of GLP and analytical practice consistent with current regulatory expectations and Global Takeda standards.
• Maintain and collaboration between the Microbiology laboratory and operations.
• Train microbiology analysts
• Schedule microbiologist work by visual management
• Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
• Oversee the Cell Therapy Manufacturing Facility environmental monitoring programme for the facility.
• Participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing.
• Oversight of contract testing laboratories associated with microbiological testing
• Manage the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence. Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed observing SOP.
• Manage an laboratory documentation system. Prepare documents.
• Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate, and customer).
• Lead projects, quality programmes and continuous improvement programmes within the Quality department and in other departments.
• Maintain standards of safety to provide a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe.
• Be designee for the Plant Microbiologist in their absence.
• Participate in global project teams relating to Microbiology and wider quality activities.

What you bring to Takeda:

• Degree in Microbiology or other relevant field.
• More than 4 years' experience working in Microbiology in the pharmaceutical industry in a Biologics company
• Experience of microbiology testing including Sterility, endotoxin, mycoplasma and Environmental Management
• Knowledge of GMP and current FDA & EMEA regulations
• Experience of Lean Laboratories is preferable
• Previous experience setting up a new Microbiology laboratory is desirable
• Microbiology knowledge, with the ability to act as a Subject Matter Expert

What Takeda can offer you:

• Great compensation package and performance-based bonus
• Employer retirement plan contributions
• Employee Stock Purchase Plan
• Revenue approved profit share scheme
• Employer funded income protection
• Employer funded private medical insurance with dependants' cover
• Employer life insurance contributions
• Electric charging points available at parking locations
• Employee Assistance Program
• Wellbeing and engagement teams
• Takeda Resource Groups
• Family friendly policies
• 26 vacation days plus additional days for service milestones
• Educational programmes and formal training
• Development opportunities
• Humanitarian volunteering leave options
• Subsidized canteen
• Flexible employee funded options like Dental Insurance, Partner Life Insurance, Serious Illness Protection, Fuel Card, Bike to Work, Commuter Ticket, and Insurance Deals

More about us:

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines.

Takeda Ireland was established in 1997. Our story in Ireland is one of substantial growth, rapid change, and. Over the past two years, Takeda Ireland has invested over €55 million in Ireland to develop our manufacturing sites. Solidifying our commitment in our people and contributing to the local economy. Takeda in Ireland has commercial operations, corporate services, and manufacturing facilities across four locations: Baggot St, Bray, Citywest, and Grange Castle. We have been certified as Top Employer for several consecutive years.

How we will support you:

Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, colour, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status or any other characteristic protected by law. If you are living with disabilities, chronic illness, or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process.

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