Teamlead GMP Production Bioconjugation BioDS (m/f/d)

During the project phase Participation in the planning/design of the corresponding production area taking into account GMP and EHS inspections Participation in factory or Site Acceptance Tests, commissioning and qualification of the new production plant Participation in the production start of the new plant and transfer of the production team and the production plant to the GMP plant Creation of production documents, SOPs, risk analyses and other GMP/EHS documentation together with the team and, if applicable, external service providers Construction and development of the future production team After completion of the project, you take responsibility as a team leader for the newly built area of the GMP bioconjugation. This allows you to significantly shape your future work area During routine production Responsibility for a production team in the biopharmaceutical plant for the production of antibody active substance conjugates Ensuring timely and efficient production taking into account resource planning and plant occupancy Leadership, motivation and development of a team of production staff in shift operation Continuous improvement of production processes taking into account technological, economic and GMP and EHS requirements Compliance with quality requirements and performance of quality-relevant tests, cooperation in qualification and validation activities, and representation of the production area in audits and inspections Participation in the processing of pharmaceutical deviations, testing of production documents, SOPs and production reports Implementation of training measures

Completed (specialized) university studies in biotechnology, pharmaceutical technology, process engineering or a comparable qualification such as technicians or master's degree with long-term professional experience and employee management Experience with the biopharmaceutical production and handling of single-use equipment Ability to motivate and manage a team as well as enforcement and intercultural cooperation High technical understanding of process plants and a strong awareness of quality and GMP requirements Interest in innovative technologies and methods for digitization as well as knowledge of common production IT tools (MES, SAP, etc.) Careful, conscientious and independent working in the GMP environment and willingness to shift work Very good knowledge of German and English in word and writing

Attractive Benefits Work-life balance Personal growth and development Health and well-being