GMP Production Operator and Deputy Production Team Leader [Switzerland]

 

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Wyss Zurich Translational Center

GMP Production Operator and Deputy Production Team Leader
100 %

The Wyss Zurich is a joint accelerator of the ETH Zurich and the University of Zurich, which was made possible by a generous donation from the Swiss entrepreneur and philanthropist Dr. hc. mult. Hansjörg Wyss. The mission of Wyss Zurich is to drive the clinical translation and technology transfer of outstanding scientific discoveries into new therapies for patients and breakthrough innovations in the emerging fields of Regenerative Medicine and Robotics, and to promote hybrid technologies in these fields. Wyss Zurich brings together some of the world's leading experts to form multidisciplinary teams, pooling their knowledge and expertise.

The project MUVON is developing a low-risk, minimally invasive treatment that uses the patient's own muscle precursor cells (MPC) to regenerate the damaged sphincter muscle, thus potentially providing a cure for stress urinary incontinence, as the first target indication. Currently working on a Phase II clinical trial evaluating the efficacy of the approach, the MUVON project has been supported by Wyss Zurich and will now proceed with the development of their therapy and undertake all required activities for regulatory approval. We are a multicultural team with outstanding dedication to bringing a significant change in patient's lives and have founded the UZH Spin-off MUVON Therapeutics in 2020 which is linked to this project.

Your responsibilities

We are looking for an ambitious and flexible GMP operator to support the production of an autologous cell product for use in a clinical trial and take over production team leader duties as deputy.
The position will be mainly focusing on GMP associated work but can also extend to research and development in the laboratory where the current established process is further developed for later stage clinical trials.
You will be able to join a young and dynamic start-up team and will be working in a grade B cleanroom (in collaboration with Wyss Zurich Translational Center facility at Moussonstrasse) to support the production of muscle precursor cells from patient biopsies in a GMP compliant manner. Furthermore, you will support the current production team leader in routine quality tasks associated to the daily GMP work.

Responsibilities:

• GMP-compliant cell production in the GMP cleanroom facility (primary cell production, analysis according to current GMP regulations)
• Organization and coordination of GMP tasks with the MUVON production team as well as the Wyss platform
• Performance of routine quality tasks of an ongoing production for clinical trial
• Preparation of official authority documents and support during regulatory submissions
• Clear and structured data organization for precise documentation

Your profile

• Education level: Master's degree in Biology, Biotechnology or a similar field with previous responsibility for your own projects
• Strong experience in mammalian cell culture is mandatory.
• Previous GMP experience (documentation + manufacturing) required
• Open and ready to work in GMP cleanroom class B as well as maintain the established and project-related QMS documentation (event documentation, CAPAs, CCs, working instructions, specifications etc.).
• Precise working habits, strong attention to detail, ability to work under time pressure and to prioritize tasks accordingly
• Flexible working times, willingness to commute between the lab (Schlieren), GMP facility (Moussonstrasse, ZH city) and the office space (Weinbergstrasse, Zurich city).
• Ability to plan, coordinate and execute projects independently and as part of the R&D/GMP team.
• Solid communication & writing skills in English and German required.
• Command of Microsoft Office required.

What we offer

We are a young, energetic team with outstanding dedication to bringing a significant change in patient's lives. Therefore, we have founded the UZH Spin-off MUVON Therapeutics in 2020, which is linked to this position and the phase II study. Our goal is to further strengthen the GMP team for the phase II productions at the Wyss Zurich Translational Center, as well as the preparation for later stage clinical trials and also provide an opportunity to extend employment through MUVON Therapeutics and participation in Startup success.

Place of work

Moussonstrasse, Zürich, Switzerland

Start of employment

The employment start date is 01.10.2023.

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