Beschreibung

In this role, you will lead the Tech Area of a non-GMP pilot plant, focusing on pioneering production processes for biopharmaceuticals. Your day-to-day responsibilities will involve collaborating with various teams, implementing new technologies, and ensuring compliance with safety regulations.

Anforderungen

• •Advanced university degree in Natural Sciences or Engineering
• •Minimum 5 years of professional experience
• •Experience in production and purification of biologics
• •Experience in scale-up and continuous production processes
• •Experience with mammalian cell culture
• •Experience with digitalization initiatives
• •Experience in identification, evaluation and implementation of new technologies
• •Experience in leading teams with direct personnel responsibility
• •Experience in project management in international contexts
• •Strong teamwork and communication skills
• •Excellent organizational skills
• •Collaborative spirit for open exchange in teams
• •Independent work style and solution-oriented approach
• •High self-motivation, reliability, and sense of responsibility
• •Pioneering spirit and willingness to continuously learn
• •People leadership according to Sanofi values
• •Extensive knowledge and experience with production processes for biological products
• •Extensive process engineering understanding in scale-up of processes
• •Experience with continuous production processes
• •Knowledge in bioanalytics
• •Programming skills and tools for data analysis
• •Knowledge in process digitalization
• •Knowledge in process transfers
• •Knowledge in implementing regulatory requirements
• •Analytical thinking and approach
• •Very good IT skills and knowledge in handling modern systems
• •Excellent German and English skills, both written and spoken

Aufgaben

• •Set up and lead the Tech Area for non-GMP pilot plant production
• •Establish continuous production processes for microbial drug substances
• •Evaluate and implement new technologies at technical scale
• •Conduct feasibility assessments of GMP facilities
• •Plan, scale up, and analyze technical material for microbial projects
• •Characterize equipment and develop predictive models for scalability
• •Collaborate with development units and non-GMP production heads
• •Introduce electronic systems and AI solutions for process digitalization
• •Organize and optimize lab procedures according to guidelines and safety regulations
• •Plan, execute, and document experiments with in-process analytical methods
• •Ensure efficient transfer of processes to GMP pilot plants and other sites
• •Maintain facilities and adapt them for new projects
• •Contribute to regulatory documentation preparation
• •Lead and develop assigned employees in line with company values

Tools & Technologien

Benefits