Manager
Mainz, Germany | full time | Job ID : 8958
At the iNeST facility, cancer therapeutics will be produced individually for each patient in order to meet their personal needs. The Pilot Facility is designed for high-throughput production.
Your main responsibilities are :
Creation and maintenance of the validation concept for the Pilot FacilityPlanning of validation activities for the establishment of new products and optimization of existing processes, including the creation of validation reportsTechnical leadership in validation activities (process validation, cleaning validation, etc.)Responsible for training the operational departments on the validation activitiesCreation and maintenance of process-relevant documents (process risk analyses, process descriptions, etc.)What you have to offer :
Degree in Pharmacy, Biotechnology, Natural Sciences, or Engineering4-5 years of relevant experience in a regulated GMP environmentProfessional experience in process validations of biotech productsSolid knowledge of US and EU regulations and experience in dealing with respective authoritiesExcellent communication and organizational skillsDetail-oriented, excellent problem-solving skills, and critical thinking abilitiesFluent in German and EnglishPlease note that this position is a limited replacement for parental leave. Your Benefits : It's our priority to support you :
Your flexibility : flexible hours | vacation accountYour growth : Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn LearningYour value : Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potentialYour health and lifestyle : Company bikeYour mobility : Job ticket | DeutschlandticketYour life phases : Employer-funded pension | Childcare