Beschreibung

In this role, you will pioneer continuous production processes for microbial drug substances, collaborating closely with various teams to innovate and optimize workflows while ensuring compliance with safety and regulatory standards.

Anforderungen

• •Advanced university degree in Natural Sciences or Engineering or minimum 5 years of professional experience
• •Experience in production (USP) and purification (DSP) of biologics with microbial systems
• •Experience with mammalian cell culture beneficial
• •Experience in scale-up and continuous production processes
• •Experience in identification, evaluation and implementation of new technologies
• •Experience in project management in international and interdisciplinary contexts
• •Strong teamwork and communication skills
• •Excellent organizational skills
• •Collaborative spirit for open exchange in crossfunctional teams
• •Independent work style and solution-oriented approach
• •High self-motivation, reliability, and sense of responsibility
• •Pioneering spirit and willingness to continuously learn
• •Knowledge and experience with production processes for biological products
• •Process engineering understanding and knowledge in scale-up of cultivation and purification processes
• •Knowledge of continuous production processes
• •Knowledge in bioanalytics
• •Knowledge in process digitalization
• •Programming skills and tools for data analysis beneficial
• •Analytical thinking and approach
• •Very good IT skills (MS Office) and knowledge in handling modern, IT-supported plant systems
• •Excellent German and English skills, both written and spoken

Aufgaben

• •Support production of non-GMP technical drug substance materials
• •Evaluate and implement new technologies for continuous production processes
• •Plan and scale up microbial projects at non-GMP technical scale
• •Characterize equipment and develop predictive models for scalability
• •Introduce electronic systems and AI solutions for process digitalization
• •Organize and optimize lab procedures following safety regulations
• •Plan, execute, and document experiments with in-process analytical methods
• •Ensure efficient transfer of processes to GMP pilot plants
• •Maintain assigned facilities and adapt them for new projects
• •Collaborate with development units and represent non-GMP Pilot Plant in projects
• •Study literature and attend congresses to identify innovative methods

Benefits