The purpose of the role is to manage the Quality Control laboratories for Cell Therapy medicinal products manufactured at a brand new Biologics cell therapy lab in one of the world's leading pharmaceutical and Biotechnology company's. The QC Laboratory Manager has responsibility for both the QC testing and Microbiological Testing activities for the companies Cell Therapy manufacturing facility.
Day to day:
- Responsible for the overall management of separate Quality Control laboratories supporting the manufacture of Cell Therapy. The QC laboratories operate on 24/7 and other shift rotas as required.
- Ensure that QC laboratories are set up and operate 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.
- Develop and maintain excellent communication and collaboration between QC and other work areas.
- Supervise QC Executives including training, recruitment, motivation, discipline and performance appraisal.
- Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all QC and microbiological samples.
- Lead the QC work stream of tech transfer and start-up of Cell Therapy products assuring the milestones of the project are reached.
- 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 as per SOP.
- Degree in Science or other relevant field.
- More than 10 years' experience in the Pharmaceutical/Biopharma industry and minimum of 5 years QC Laboratory Management experience
- Experience in Cell Therapy product testing would be advantageous
- Extensive experience of both chemistry and microbiological testing
- Strong analytical knowledge, particularly in HPLC and Flow cytometry
For immediate consideration apply with an up to date CV.
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Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales