Production Operator - Pharmaceutical Environment 100 %
100 %
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.
- 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.
- 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