Celonic is a “Pure Play” Biologics Contract Development Manufacturing Organization (CDMO). Celonic has set itself the task of effectively bringing its customers, primarily small to large biotech companies, to the marketplace, life-saving and improving drugs using innovative next-generation bioprocess technologies. Celonic has a state-of-the-art development and innovation centre in Basel, Switzerland, as well as clinical and commercial GMP production facilities in Heidelberg, Germany. More than 500 highly qualified employees currently work at Celonic. Due to the expansion of the company, Celonic is looking for dedicated and qualified employees.

As a (Senior) Process Specialist (w/m/d) you will be the interface between development (Celonic-Basel) and the USP/DSP Process Teams with the Buffer & Media Team. They support the planning, monitoring and implementation of manufacturing processes for biopharmaceutical active ingredients and pharmaceuticals, perform external and internal technology transfer activities and accompany the entire product life cycle at the operational level. In addition, you contribute to the continuous process improvement by reporting and data evaluation and are responsible for the independent implementation of validations, tests and the compilation of batch records as well as for the production and testing of production documentation and SOPs in the field of expertise. Your enquiry area: Support of the Process Lead in the planning, monitoring and implementation of processes for the production of biopharmaceutical active substances and pharmaceuticals Implementation of internal and external technology transfer activities in the clinical or commercial field Accompanying the entire Product Life Cycle from technology transfer to the production phase to the completion and completion phase at operational level Contribution to continuous process improvement through the creation and evaluation of reports and the own evaluation of production data Implementation of Cause Analysis and Risk Assessments Self-fulfilment of process validations to ensure that products meet regulatory requirements Examination and compilation of executed batch records Creation and testing of production documentation and SOPs to improve efficiency and product quality, and processing of deviations, changes and CAPAs in the field of expertise

Complete studies in life sciences, biotechnology, biology, biochemistry or comparable qualifications At least 3 years of professional experience in the pharmaceutical or biotechnological environment Representative expertise and technical understanding of production facilities and associated processes in the production of buffers and media Experience in implementing the technology transfer of (commercial) production projects Very good understanding of GMP and other regulatory requirements Detectional ability to identify, prioritize and contact key stakeholders in German and English Safe handling in the application of Microsoft Office Clear communication, very good knowledge of German

Take influence together on the lives of patients Biotechnology is an attractive, high-growth sector with career development opportunities Celonic offers a multinational, diverse working environment We are proud to be a pioneer of “Next Generation” in manufacturing technologies Celonic is family-owned: entrepreneurial and with short communication paths Heidelberg is a great place to live, leisure and work in the heart of Europe JOBV1_EN