Are you a dedicated and experienced Manufacturing Specialist ready to take on a pivotal role in the development of advanced cell and gene therapies? At the Princess Máxima Center for pediatric oncology, we are at the forefront of innovation, working to transform lives through cutting-edge cancer treatments. To further shape the CGU in this start-up phase, an exciting opportunity is available for an experienced and highly motivated Manufacturing Specialist to join the new Cell and Gene Therapy Unit team. This is your chance to make a real difference in a pioneering environment, contributing to breakthrough therapies that impact patients worldwide.
About the Cell and Gene Therapy 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.
Your Key Responsibilities
As a Manufacturing Specialist, you will play a key role in producing clinical cell therapy products, ensuring they meet stringent regulatory and accreditation standards.
Your responsibilities include:
- Executing all tasks related to the manufacturing of clinical cell therapy products, ensuring production timelines are met.
- Organizing and managing human clinical biomanufacturing campaigns, delivering final cellular products for therapy.
- Supporting the planning and implementation of cGMP projects at both upstream and downstream levels to deliver advanced therapies to patients.
- Training team members on manufacturing processes and coordinating with stakeholders during tech transfer activities to implement new processes.
- Preparing and revising SOPs, Work Instructions, and Batch Records, as well as implementing digital solutions for electronic Batch Record management.
- Participating in the development of strategies to innovate production systems and optimize manufacturing processes.
- Identifying process optimization opportunities and driving improvements.
- Collaborating closely with QA colleagues to address manufacturing deficiencies and recommend CAPA for batch records.
- Contributing to the process development of new therapies and translating research findings into clinical products.
- Supporting the implementation of the Manufacturing Execution System (MES).
Your Profile
You are a motivated and resourceful professional, ready to embrace the challenges of manufacturing in a high-stakes environment. You excel in working collaboratively within multidisciplinary teams and are driven to innovate and deliver high-quality therapies.
Additionally, you bring:
- A university degree in Biomedical, Life Sciences, or a related field.
- Hands-on experience in clinical cell therapy product manufacturing, ideally with HSCTs, CAR-T, T cells, gene editing, and aseptic cGMP cell culture techniques.
- Proficiency with MES and electronic quality systems.
- Solid knowledge of the EU regulatory and accreditation framework for cellular therapy product production.
- Experience in creating and managing SOPs, batch manufacturing records (BMRs), and other documentation for clinical manufacturing.
- A blend of analytical and practical problem-solving skills, with the ability to manage a varied workload effectively.
- Strong interpersonal skills, fostering collaboration and team success.
- A proactive mindset, with the ability to develop innovative solutions for complex challenges.
- Excellent verbal and written communication skills in English; proficiency in Dutch is a valuable 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 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’.
If you do not yet fully meet all the job requirements but are motivated and eager to learn, we still encourage you to apply! In that case, your salary will start in FWG 50.
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 pediatric 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 center brings together the best possible care and scientific research, creating a unique interdisciplinary institute for pediatric 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, Cell and Gene Therapy Unit.
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