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Plaats

Utrecht
Utrecht
Nederland

Contract

Vooltijds, Onbepaalde duur

Datum gepubliceerd

2025-12-08

Online tot

2026-02-06
EUR 20.00 HOUR

Quality Control (QC) Specialist - Cell Therapy Facility

Prinses Máxima Centrum voor kinderoncologie
Utrecht Utrecht
1 dag geleden

Are you an experienced Quality Control (QC) Specialist looking to make a meaningful impact? At the Princess Máxima Center for pediatric oncology, you will work at the forefront of innovation, helping to develop advanced cell and gene therapies that have the potential to transform lives. To further shape our new Cell and Gene Therapy Unit (CGU), we are seeking a skilled and motivated QA Specialist with a strong background in Advanced Therapy Medicinal Products (ATMPs). This is your opportunity to contribute to cutting-edge cancer treatments in a dynamic and pioneering environment. About The Cell And Gene Unit The Princess Máxima Center is building a state-of-the-art facility where the primary focus will be the manufacturing of ATMPs. Alongside production, the CGU will play a vital role in translational research to advance and refine innovative therapies. Would you like to know what it’s like to work in our CGU? Rachel shares more about her work in the Cell and Gene Therapy Unit in this article . Key Responsibilities (included But Are Not Limited To)

Perform all tasks related to the quality control testing of starting material, in-process controls, and final product post-manufacturing of clinical cell therapy products.
Ensure timely GMP release of in-process, product and stability testing results.
Undertake receipt, processing, testing, and reporting results for QC samples.
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.
Ensure timely GMP release of in-process, product and stability testing results.
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 QC department with Out of specifications, Deviations, CAPAs, Change Control, Root-Cause analysis and Personnel Training on (QC) procedures.
Development and/or (re)-validation of analytical methods according to ICH Q7 guidelines.
Participation in Maintenance/Compliance and Continuous Improvement Projects.
Assist in planning and implementing cGMP projects both at the upstream and downstream levels.
Providing and managing work schedules for the QC team.
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.
Determine where processes/methodology could be optimized and contribute to improvements that could be made.
Work closely with QA colleagues to identify excursions and deficiencies and provide recommendations for quality improvements.

Profile

University degree in Biomedical, Life sciences or another relevant area.
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.
Ability to combine an analytical and resourceful approach, and able to balance a varied workload.
Ability to establish empathetic connections with colleagues that foster relationships and improve performance.
Motivated to pioneer, take self-initiative and able to develop creative solutions to (complex) issues.
Excellent English writing and verbal communication skills are required. Fluency in Dutch will be a vital asset.
Stress resilient and able to work under pressure to meet service delivery requirements.

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 8,33% holiday allowance and 8,33 % end-of-year bonus. The Princess Máxima Center operates according to the collective labor agreement ‘CAO ziekenhuizen’. Candidates who do not yet meet all requirements but demonstrate strong motivation, transferable skills and a willingness to learn are also encouraged to apply. In such cases, the starting salary will be aligned with FWG 50. The training period will span a minimum of one year, with the exact duration depending on the candidate’s prior experience and transferable competencies. The Princess Máxima Center The Princess Máxima Center for Pediatric Oncology is an integrated hospital and research institute, which integrates healthcare, research and education on paediatric cancer, in a single location in Utrecht. Our institute aims to provide the highest level of care for all children with cancer, with optimal quality of life. The centre brings together the best possible care and scientific research, creating a unique interdisciplinary institute for paediatric oncology in Europe. 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. Acquisitie naar aanleiding van deze vacature wordt niet op prijs gesteld. Solliciteer direct Solliciteer direct Details

- 36 hours per week
- FWG: 50 - 55
- Min. €3.329,- max. €5.289,-

Contactpersoon Adeel Saleem Stuur een e-mail Deel deze pagina

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Quality Control (QC) Specialist - Cell Therapy Facility

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