Production Operator - Pharmaceutical Environment
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 laboratory technician EFZ or HFP, or minimum 2 years of work experience in a similar position.
- Experience in handling human blood cells in the BLS2 environment, cell culture and molecular biology techniques, automated cell processing systems.
- Previous experience in process development or GMP manufacturing of pharmaceuticals (preferred experience in cell product manufacturing) is an advantage.
- Knowledge of GMP regulations and guidance, and familiarity with GMP compliant manufacturing of cell products, materials and equipment qualification is an advantage.
- Fluent verbal and written communication in English. Good communication skills in German are an advantage.
- Good knowledge of MS Office
What we offer
You can expect an interesting job to which you can actively contribute to. A diverse and motivated team awaits you with the aim of bringing the therapy into a phase I/II clinical trial. We offer you well-established training in the GMP-regulated environment. The conditions of the contract and the salary are subject to the regulations at the University of Zurich, cantonal regulations and your qualifications.
Place of work
Start of employment
August 2024 or by agreement. Please submit your application documents (cover letter, CV, relevant certificates) in English or German.
Further information
Write an email
Lieu de travail
Moussonstrasse
8044 Zürich