Pharmacist - GMP (m / f / d)

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.

Activities and responsibilities

• 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)

Waht you have to offer :

Your Benefits : It's our priority to support you :