Senior QC Analyst Cell Therapy

Job Description

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Job Description Senior QC Analyst Cell Therapy Senior QC Analyst Cell Therapy - Grange Castle

About the role:

The Senior QC Analyst Cell Therapy has an important role to play in the start- up of the TIL Grange Castle Quality Control laboratory in a new Biologics manufacturing facility and the routine operation of the QC laboratory when startup is complete. The Senior QC Analyst Cell Therapy will have specific and varying tasks and some responsibilities as outlined below. During startup is important and responsibilities may change, or other tasks may arise.

Onsite work mode

On call requirement

How you will contribute:

Quality Systems:

• Contribute to the design and implementation of quality systems in the QC laboratory.
• Work with other QC personnel in the preparation and review of the required documentation in the QC laboratory, including Standard Operating Procedures, Analytical Procedures, Analytical Worksheets and Material Specifications.
• Participate, as directed, in the following activities in the QC laboratory:
• Equipment Calibration and Maintenance
• Reference Standard and Reagent Management
• Purchasing
• Lean Laboratory Techniques

Analytical Testing:

• Provide expertise in many analytical test procedures and equipment.
• Manage sampling and analytical testing of raw materials, packaging materials, intermediates, Drug Substance and Drug Products according to approved TIL Grange Castle procedures and plant schedules.
• Ensure that all testing information is recorded and completed according to TILGC procedures.
• Ensure that any deviations or out of specification (OOS) results are reported immediately to the QC Executive so that corrective action may be taken.
• Provide assistance and guidance in deviation investigations, OOS investigations, and change proposals.
• Provide samples to contract testing laboratories and collaborate with these laboratories.

Validation:

• Manage method transfer and method validation/verification work, to meet project deadlines.
• Review equipment qualification documentation for QC Laboratory equipment.
• Good Laboratory Practices:
• Ensure that Good Laboratory Practices are followed.
• Ask, if in doubt, about any practice or unusual finding.
• As a member of the quality function, work with other departments to promote a culture of compliance to Good Manufacturing Practice within the plant.

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 Standard Operating Procedures, reading, training and assessments.
• Other tasks and directed by the relevant Manager or other Officer appointed by the Board of Directors.

What you bring to Takeda:

• Minimum of a BSc Degree (Life Science/ Biotechnology)
• 2 years' work experience in a regulated GMP/GLP environment
• Practical experience with HPLC systems and troubleshooting
• Practical experience in cell counting, morphology and flow cytometry is desirable
• Experience writing SOP's / validation protocols
• Experience with Method transfer / validation/verification, desirable but not essential
• Experience working in a Biologics facility, desirable but not essential
• Familiarity with CDS and LIMS is desirable but not essential
• Demonstrated to support a growing organisation.

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 programs 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 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.

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