QC Microbiology Executive, Cell Therapy Facility - Grange Castle
Company: Takeda Pharmaceutical
Posted on: June 22, 2022
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
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
- 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
- People manager responsible for recruiting, managing, training,
development and performance reviews from project phase into
- 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
- 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
- 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
- Drive and promote the corporate values of Takeda-ism within the
- 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 in Cell Therapy product testing would be
- 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
- Knowledge and experience of Lean Laboratories is
- Excellent knowledge of Good Manufacturing Practice for aseptic
pharmaceutical manufacture as described in current FDA & EMA
- Ability to motivate and leading a team.
- A high level of initiative is required
- Excellent verbal and written communication skills are
- 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
- 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
Didn't find what you're looking for? Search again!