Scientist for quality assurance and production of cell products

Cell2Cure is looking for a scientist with experience in GMP and cell biology.

We expect you to have a high professional commitment, to be organized and thorough, and to have an interest in GMP, quality assurance and cell biology.
Ideally you hold a master’s degree in health sciences or natural sciences, and you have practical experience with cell culture, and/or aseptic GMP manufacturing, and quality assurance there off. General knowledge of regulatory requirements for advanced therapy will be an advantage.

We can offer you a position where you can help make a difference for colleagues and patients alike. You will be part of a hectic but committed innovative environment with a strong interdisciplinary collaboration. We guarantee you, that no two working days are the same.

Cell2Cure

Cell2Cure is a small Danish biopharmaceutical company that develops and produces investigational medicinal products based on stem cells isolated from adipose tissue. Today, our cell products are being tested in multiple clinical trials and diseases, nation-wide.

Our manufacturing process is partially automated and includes isolation of cells from tissues, propagation of cells in bioreactors, cryopreservation, and quality control.

We are at the forefront of the development of clinical stem cell therapy. That requires drive and creativity and is rewarded with great
responsibility and influence on decision making. You will be given an active role in a small group of dedicated entrepreneurs and developers, all
with many different tasks, and the skills to pull together.

We believe that the best way to evaluate and assure quality of Cell2Cures cell products, is to have a practical insight into the manufacturing
process. Therefore, we expect you to play an active role in GMP production, trouble shooting and improvement of the manufacturing process
as well as the associated quality system.

The job

You will help ensure that Cell2Cures manufacturing meets the current European GMP standard for the quality of Advanced Therapy Medicinal
Products.

This will include tasks such as:

• Risk assessments, and deviation management
• Drafting of change requests and change control
• Preparation of recommendations for corrective and preventive actions
• Qualification of premises and equipment
• Preparation of quality standards and procedures
• Monitoring and audit of contractors and suppliers
• Improvement of existing quality assurance system
• Practical assistance during manufacturing and process development

In return, we offer you a job with multiple branches of learning, and the possibility to influence progress in collaboration with a dedicated team.

Interested?

If you wish to be at the forefront of Danish translational stem cell development, where challenges are huge and the pace is fast, but
commitment exceeds both, – we look forward to receiving your application.

We will process applications as we receive them and will have interviews with qualified candidates as we identify them, so please send your
application as soon as possible.

For any further questions, please do not hesitate to contact Annette Ekblond telephone no. +45 21 78 28 24.

Cell2Cure is currently expanding. You will be one of several new colleagues also associated with production, quality control and regulatory affairs.