QC Microbiology Executive, Cell Therapy Facility - Grange Castle

Company: Takeda Pharmaceutical
Location: Dublin
Posted on: June 22, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:The QC Microbiology Executive is responsible for the day-to-day management of the Microbiology Laboratory for Cell therapy medicinal products manufactured at the P3 Cell therapy manufacturing facility in Takeda Ireland Ltd, Grange Castle. The QC Microbiology Executive has responsibility for Microbiological testing activities for the Cell Therapy manufacturing facility.As with all site personnel, the QC Microbiology Executive is responsible for promoting a culture of Regulatory Compliance and Continuous Improvement within the Quality Control and across the Cell Therapy manufacturing plant and the TILGC site.Fully onsite work mode.How you will contribute:The responsibilities of the QC Microbiology Executive include the following:

• Responsible for the overall management of the Microbiology laboratory supporting the manufacture of Alofisel product.
• Establish and lead the Microbiology team supporting the technical transfer of Alofisel through to operation readiness: Method Transfer/Validation, Contamination control strategy, Aseptic training, Environmental Monitoring program, raw materials testing, product testing, in-processing testing, process validation and facility validation.
• People manager responsible for recruiting, managing, training, development and performance reviews from project phase into sustaining production.
• Responsible for the operation and inspection readiness of the Microbiology laboratory by ensuring the laboratory operates in compliance with current Good Laboratory Practice / Good Manufacturing Practice at all times. Implement and maintain standards of GLP and analytical practice consistent with current regulatory expectations and Global Takeda standards.
• Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
• Manage the environmental monitoring to support the manufacturing of the Alofisel.
• Lead and participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing.
• Manage 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/Limits (OOS/OOL) or Out of Trend (OOT) analytical results are managed as per SOP.
• Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate, customer).
• Actively lead and support projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas.
• Implement and maintain standards of safety to ensure a safe working laboratory.
• As required, act as designee for the Microbiology Laboratory Manager in their absence.
• Participate as required in global project teams relating to Microbiology and wider quality activities
• Participate fully in any cross functional training initiatives.
• Drive and promote the corporate values of Takeda-ism within the workplace.
• Actively foster, in cooperation with other staff, an ethos and culture of Quality and Safety awareness where safety is accepted as an integral part of the overall business.
• Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
• Coaching, Mentoring and development of the Microbiology AnalystsWhat you bring to Takeda:
  • Degree in Microbiology or other relevant field.
  • More than 7 years' experience in the pharmaceutical/Biopharma industry and minimum of 3 years at Supervisor/Senior Micro Analyst experience
  • Experience in Cell Therapy product testing would be advantageous
  • Extensive experience of microbiological testing
  • Experience in audit preparation and participation
  • Knowledge of GMP and current FDA & EMA regulations
  • Previous experience in managing the performance of individual team members and that of the overall team would be advantageous
  • Knowledge and experience of Lean Laboratories is preferable
  • Excellent knowledge of Good Manufacturing Practice for aseptic pharmaceutical manufacture as described in current FDA & EMA regulations.
  • Ability to motivate and leading a team.
  • A high level of initiative is required
  • Excellent verbal and written communication skills are essential.
  • Strong project management and report writing skills
  • Ability to adapt to changing priorities
  • Strong knowledge of aseptic process, aseptic process simulations(media fills), sterility and endotoxin testing and validation.What Takeda can offer you:Full Healthcare Cover - includes dependentsPension SchemeAttractive BonusSubsidised canteenParking facilities with electric car charging pointsHealth & Wellness programs including onsite flu shots and health screeningsEducational AssistanceImportant Considerations:At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
    • Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
    • Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
    • Work in a cold, wet environment.
    • Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
    • Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will 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, color, 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.LocationsGrange Castle, IrelandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Dublin , QC Microbiology Executive, Cell Therapy Facility - Grange Castle, Healthcare , Dublin, California