Process Expert DSP(m/w/x)

## Process Expert (m/f/x) DSP ## Purpose of the function: The process expert Downstream Processing (DSP) is a key member of the BioDS project team and drives the project in the workstream process DSP. Initial focus of the role is timely completion of activities (process-related, qualification-related and related to ,,GMP readiness‘‘) to ensure establishment of mammalian cell culture capabilities in course of the BioDS project as committed to Japan. Later, the role is expected to focus on clinical trial material (CTM) production and commercial mAb production in the respective GMP suite(s) in the BioDS building B02. ## Roles & Responsibilities: * The incumbent closely works with the engineering company responsible for the process design and is the direct contact for all project phases from basic design, detail design into construction and commissioning with the OQ being the expected final project phase. * Essential duties include draft and timely review of documents provided by the engineering contractor such as URS, FS, HDS, timelines, cost estimates,...for factual correctness and suitability for the project. The process expert DSP will also ensure best possible floor planning, equipment positioning, process and material flow for manufacturability. Close cooperation with DSJ (BTRL Tatebayashi) is required to align and drive decisions on process equipment, tech transfer topics as well as knowledge exchange for future projects. * In addition, it is planned to establish disciplinary leadership for the downstream team as the project moves into process transfer and preparation for IQ / OQ and PQ. ## Professional experience & Education: * Ph.D. or master's degree in Life Sciences (e.g., Biology, Biochemistry, Biotechnology, Chemistry or related field) * Significant professional experience (minimum 5 years) in biotech projects for mammalian cell culture USP and DSP processes, ideally working directly * with single-use equipment. * Leadership Experience: Experience in leading and managing teams in a direct reporting line and also in matrix structures * Knowledge in MS Office suite, particularly MS Project ## Personal skills: * Fluency in English, German mandatory * High attention to detail and very good problem-solving skills * Strong communication and organizational skills