Manufacturing Specialist – Cell Therapy Facility

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 Therapy Facility (CTF). 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 CTF in this building phase, an exciting opportunity is available for an experienced and highly motivated Manufacturing Specialist to join the new Cell Therapy Facility team.

Key responsibilities (included but are not limited to):

  • Perform all tasks related to the manufacturing of clinical cell therapy products.
  • Organise and execute human clinical biomanufacturing campaigns, preparing the final formulated cellular product for therapy within production timelines and adhering to all regulatory and accreditation standards.
  • Assist in planning and implementing cGMP projects both at the upstream and downstream levels.
  • Train team members on manufacturing processes and liaise with stakeholders during tech transfer activities in implementing new processes.
  • Prepare and revise SOPs, Work Instructions and Batch Records as needed. Implement digital solutions for an electronic Batch Record management system.
  • Participate in developing strategies to innovate production systems and manufacturing processes.
  • Determine where processes need to be optimized and contribute to improvements that could be made.
  • Work closely with QA colleagues to identify excursions and deficiencies during manufacturing and provide recommendations for CAPA for batch records.
  • Participate and take an initiative in the process development of new therapies as required and translational of new research into a clinical product.

Profile

  • University degree in Biomedical, Life sciences or another relevant area;
  • Experience in clinical cell therapy product manufacturing is desirable, particularly related to HSCTs, CAR-T, T cells and gene editing, as well as extensive experience in aseptic technique and cGMP cell culture;
  • Adequate knowledge of EU regulatory and accreditation framework required for the production of cellular therapy products;
  • Experience in generating SOPs, batch manufacturing records (BMRs) and other documentation for clinical manufacturing of cell and gene therapy products;
  • 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.

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 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’.

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 (A.Saleem-3@prinsesmaximacentrum.nl).

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