Production Operator

vor 5 Monaten

Zurich, Schweiz Wyss Zurich Translational Center Vollzeit

Wyss Zurich Translational Center_
**Production Operator - Pharmaceutical Environment**
**100 % **:The Wyss Zurich Translational Center is a joint accelerator of the ETH Zurich and the University of Zurich, which was made possible by a generous donation from a 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.

Project Somagenetix is developing a gene therapy for children with primary immunodeficiency. We are seeking a Production Operator to join our team. As a member of the production team, you will make an important contribution to the Good Manufacturing Practice (GMP) compliant production of genetically modified hematopoietic stem cells for a phase I/II clinical trial.

**Your responsibilities**:

- Participation in the manufacturing process. Work aseptically in a clean room environment with human hematopoietic stem cells and vector technologies (BSL2).
- Execution of all assigned manufacturing activities in accordance with the production plan and the applicable GMP, safety and environmental guidelines.
- Production of GMP documents. Documentation of manufacturing steps, recording of deviations and assistance with the appropriate measures in line with the GMP requirements.
- Execution of studies as part of the process development team. Assistance in cell culture, viral transduction, and performance of analytical methods. Maintenance of up-to-date, accurate and comprehensive documentation records and reports.
- Preparation and maintenance of equipment and environment for use.
- Management of material supply and storage (inspections and documenting of deliveries, stocking, release etc.).
- Participation in all role-relevant training and maintenance of the required training levels.
- Commitment and willingness to continuously improve.

**Your profile**:

- Bachelor's degree in life sciences or minimum 2 years of work experience in a similar position. Advanced degree with relevant experience will be considered.
- Minimum of 2 years of experience in process development or GMP manufacturing of pharmaceuticals (preferred experience in cell product manufacturing).
- Experience in handling of human derived material in the BLS2 environment, cell culture and molecular biology techniques, automated cell processing systems.
- Familiarity with GMP compliant manufacturing of cell products, materials and equipment qualification is an advantage.
- Knowledge of GMP regulations and guidance relevant to cell and gene therapy manufacturing is an advantage.
- Fluent verbal and written communication in English. Good communication skills in German is an advantage.
- Good knowledge of MS Office

**Place of work**: Moussonstrasse, Zürich, Switzerland

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