Aufgaben

• Set-up and monitor of GMP-production of solution, filling and labeling
• Set-up of GMP-production of consumables (plastic parts) for clinical transfection
• Monitoring of all suppliers of the supply chain
• Make independent production-related decisions bases on regulatory and compliance knowledge
• Collaborate with internal QA management and team members to ensure alignment with current site policies, procedures and SOPs
• Maintain sense of urgency to manage production aspects of project to ensure timelines are met

Qualifikationen

• Diploma / Master of Science and/or PhD in Life science, Process engineering
• Manages internal and external customer relations professionally and effectively
• Knowledge in Regulatory and GMP-production (3-5 years)
• Experience in setting-up a supply chain for GMP-production, ideally for clinical transfection (Manufacturing and filling of solutions and manufacturing of consumables (injection molding parts))
• Fluent in Geman and English