Specialist Manufacturing Processes Operations (m/f/d) Mainz, Germany | full time | Job ID:8410 At the iNeST facility, cancer therapeutics will be produced individually for each patient in order to meet their personal needs. The role of Specialist Manufacturing Processes supports the daily operations in production to enable smooth production. As support for the subject matter experts (SMEs), the role holder possesses in-depth process knowledge in the areas of DNA production, RNA production, lipoplexation, fill & finish, labeling, packaging and visual inspection. Tasks include root cause analysis and risk assessment for process deviations and the definition of corrective and preventive measures. The Specialist Manufacturing Processes New iNeST coordinates change control. Support for subject matter experts (SMEs) regarding product and process knowledge for the production of individualized cancer therapy (DNA production, RNA production, lipoplexation, fill & finish, labeling, packaging and visual inspection) during the project phase Handling of deviations occurring during the production process Creation of area-specific documents (e.g. SOPs, working procedures, forms) Definition and implementation of corrective and preventive actions (CAPA management) Coordination of change procedures in production (Change Owner) University degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area 2 years of experience in manufacturing/production or relevant experience, ideally in a biotech or pharmaceutical company Good knowledge of EU GMP regulations General understanding of technical processes High carefulness and accuracy in the way of working, conscientiousness, and detail-orientation Refined colloquial and correspondence skills in English (B2) and in German (B2) It's our priority to support you: Your flexibility: flexible hours | vacation account Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential Your health and lifestyle: Company bike Your mobility: Job ticket | Deutschlandticket Your life phases: Employer-funded pension | Childcare