The Princess Máxima Center for Pediatric Oncology is a unique interdisciplinary institute that brings together all the highly complex care, research, and education to provide the best possible care for children with cancer. This concentration and integration of specialized pediatric oncology reflect our mission: to provide a cure and optimal quality of life for every child with cancer. Close cooperation between care and research will lead to more children being cured of cancer, with fewer adverse effects later in life.
The Princess Máxima Centre has initiated the design and building of a new Cell and Gene Therapy Facility (CGTF). In this facility, manufacturing Advanced Therapy Medicinal Products (ATMPs) will be our primary goal. Next to that, we will participate in translational research.
To further shape the CGTF in this building phase, an exciting opportunity is available for an experienced and highly motivated Quality Control (QC) Specialist to join the new Cell and Gene Therapy Facility team.
Key responsibilities (included but are not limited to):
- Perform all tasks related to the quality control testing of incoming goods, starting material, in-process controls, and final product post-manufacturing of clinical cell therapy products.
- Undertake receipt, processing, testing, and reporting results for QC samples ensuring timely GMP release of in-process, product and stability testing results.
- Undertake management of environmental monitoring samples, recording and reporting of results and support further investigation as required (e.g., species ID investigations).
- Perform housekeeping of sample management and archive of QC samples.
- Participate in the purchase and qualification of equipment for QC testing.
- Prepare and revise SOPs, Work Instructions and Batch Records as needed from the QC testing perspective.
- Support the QA department with Out of specifications, Deviations, CAPAs, Change Control, Root-Cause analysis, and Personnel Training on (QC) procedures.
- Participation in Maintenance/Compliance and Continuous Improvement Projects both at the upstream and downstream levels, including development and/or (re)-validation of analytical methods according to ICH Q7 guidelines.
- Train team members on QC processes and liaise with stakeholders during tech transfer activities in implementing new processes.
- Participate in implementing digital solutions for an electronic Batch Record management system and support a paperless facility.
First of all, you master the ability to combine an analytical and resourceful approach and are able to balance a varied workload. Additionally, you are motivated to pioneer, take self-initiative and are able to develop creative solutions to (complex) issues. You have the ability to establish empathetic connections with colleagues that foster relationships and improve performance. Lastly, you are stress-resilient and able to work under pressure to meet service delivery requirements.
In addition, you have:
- University degree in Biomedical, Life sciences or another relevant area and 5 years plus experience in quality control procedures for clinical cell therapy products is desirable, particularly related to HSCTs, CAR-T, T cells and gene editing, as well as experience in aseptic technique and cell culture.
- Working knowledge of QC analytical methods in a GMP setting including flow cytometry, PCR, cell culture and cell-based methods (such as CFU assays). Experience with mycoplasma, endotoxin, and sterility testing would be an advantage.
- Adequate knowledge of the EU regulatory and accreditation framework is required for the quality control testing of cellular therapy products.
- Experience in generating SOPs, work instructions, batch manufacturing records (BMRs) and other documentation for clinical cell and gene therapy product QC.
- Excellent English writing and verbal communication skills are required. Fluency in Dutch will be a vital asset.
Working at the Princess Máxima Center
We offer a full-time position (based on 36 hours a week) in a very stimulating and interactive environment. The contract will be initially for one year, with the possibility to extend upon satisfaction. Your gross monthly salary (FWG 50 – 55) will be based on your experience and background and will include an 8,33% holiday allowance and 8,33 % end-of-year bonus. The Princess Máxima Center operates according to the collective labour agreement ‘CAO ziekenhuizen’.
Contact and application
You can apply for this position by pressing the apply button on this screen. May we invite you to apply as soon as possible, since we will close the vacancy when we have found a suitable candidate. For more information about this position, or to arrange an informal chat, please contact Adeel Saleem, Head of Cell Therapy Facility.
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