Beschreibung

In this role, you will lead a team focused on developing innovative microbial fermentation processes. Your work will involve establishing new platforms, driving digital innovation, and collaborating with various teams to ensure successful project delivery.

Anforderungen

• •Ph.D. in biochemical engineering, microbiology, biochemistry, biotechnology, or relevant area
• •At least 2 years of pharmaceutical/biotech industry experience in E. coli and/or yeast fermentation process development
• •Master's degree with minimal 5 years of experience may be considered
• •Profound knowledge and intensive hands-on experience in fermentation process development
• •Experience in process control strategies, bioreactor design, tech transfer, and related scale-up/-down principles
• •Strong statistic background with experience of DoE and MVDA
• •Hands-on experience with JMP/design expert/Modde
• •Demonstrated expertise in process modeling (mechanistic and/or data-driven models)
• •Computer programming skills (e.g., Python, R, MATLAB, or similar languages)
• •Proven track record of applying computational tools to solve complex fermentation challenges
• •Experience with process digitalization and/or implementation of new technologies
• •Positive, open-minded personality with high degree in flexibility
• •Can-do mentality, trustworthiness, and taking ownership
• •Conceptual and creative thinker with analytical excellence
• •Structured and accurate way of working
• •Excellence in project management and ability to lead cross-functional initiatives
• •Ability to work in a multidisciplinary environment
• •Excellent communication skills to diverse audiences
• •Proven ability to work efficiently, both independently or in a team setting
• •Ability to meet set goals by managing own timelines
• •Very good German skills (Certified German Level B2 or higher)
• •English (written and spoken)

Aufgaben

• •Lead a fermentation process development team
• •Establish next-generation microbial fermentation platforms
• •Provide management support and promote career development for team members
• •Develop robust and cost-efficient processes for clinical supply and commercial launch
• •Drive digital innovation in fermentation through advanced analytics and automation
• •Contribute as USP and/or DS team representative to CMC project teams
• •Collaborate with CMC Development and other functions to meet project timelines
• •Serve as technical lead for scale-up and transfer to pilot plant and commercial facilities
• •Author and review internal documentation and technical reports for IND/BLA
• •Collaborate with scientists and engineers across the biologics manufacturing network

Tools & Technologien