Senior Microbiology Analyst

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Senior Microbiology Analyst

Dublin, Ireland

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Business Area Overview

On the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:

  • Small Molecules
  • Biologics
  • Plasma
  • Cell and Gene

As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.

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  • Collaboration

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  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Top Workplace

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  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

Senior Microbiology Analyst

Job ID R0077222 Date posted Sep. 29, 2022 Location Dublin, Ireland

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Job Description

QC Senior Microbiology Analyst - Grange Castle

About the role:

Shift position - Monday to Friday 7am to 3pm / 3pm to 11pm.

You will oversee the general running of the Microbiology laboratory, Environmental Management and the aseptic technique associated with the manufacture of biologics product at Takeda Ireland Ltd, Grange Castle.

Onsite work mode.

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.
  • Develop and collaboration between the Microbiology laboratory and operations.
  • Train microbiology analysts
  • Schedule microbiologist work at 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. Review documents.
  • Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate, or customer).
  • Support projects, quality plans and continuous improvement programmes within the Quality department and in other departments.
  • Maintain standards of safety to guarantee a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe.
  • Be a designee for the Plant Microbiologist in their absence.
  • Participate in global project teams relating to Microbiology and wider quality activities.

General Responsibilities:

  • Participate in any training plans.
  • Promote the corporate values of Takeda-ism within the workplace.
  • foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an necessary part of the business.
  • Ensure that Accident Reports / Near Miss Forms are completed promptly after an event.
  • Ensure completion of all SOP (standard operation procedures), reading, training and assessment.

What you bring to Takeda:

  • Degree in Microbiology or other relevant field.
  • 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:

Full Healthcare Cover - includes dependents

Pension Scheme

Attractive Bonus

Subsidised canteen

Parking facilities with electric car charging points

Health & Wellness programmes including onsite flu shots and health screenings

Educational Assistance

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and patient support programmes. Takeda is a patient-focused company to inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, 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.

Locations

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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