Manager Cell Line Development (m/f/d)

• Technical and functional leadership of a Cell Line Development (CLD) team, including resource planning, staff development, and performance reviews
• Planning, coordination, and management of commercial CLD projects, from cloning through GMP-compliant cell banking
• Responsibility for cell line development of recombinant proteins (e.g., monoclonal antibodies and fusion proteins) in CHO and other expression systems
• Monitoring and optimization of the internal CLD workflow, in particular the fed-batch process in miniaturized bioreactor systems (ambr15, ambr250) and shake flasks
• Experience in the establishment of cell banks (MCB, WCB) in accordance with GMP requirements, including cell bank documentation and qualification, is desirable
• Preparation, review, and approval of regulatory documents such as SOPs, qualification plans, and CLD CMC sections for regulatory submissions
• Analysis, interpretation, and presentation of analytical data from cell culture, fed-batch processes, and quality analytics - both internally and to customers and authorities
• Ensuring data integrity, traceability, and a high standard of scientific documentation quality
• Close collaboration with Process Development, Quality Assurance, Regulatory Affairs, and Project Management
• Continuous development of methods, workflows, and standards within CLD, including evaluation of new technologies and automation solutions

• Scientific university degree (Master's / Diploma / PhD) in Biotechnology, Biology, Biochemistry, or a related field
• >3 years of professional experience in CLD, with in-depth practical knowledge of cloning, pool selection, characterization, and scale-up of mammalian cell lines (in particular CHO cells)
• Experience leading commercial development projects, including timeline, budget, and stakeholder management
• Demonstrable leadership experience managing scientific teams, with a proven ability to motivate, develop, and guide team members toward shared goals.
• Proven experience in preparing GMP-compliant documentation, including SOPs, qualification documents, and CMC submissions
• Strong analytical skills with experience evaluating, interpreting, and presenting complex data sets from cell culture and protein analytics.
• Excellent communication skills in both German and English (written and spoken), enabling effective collaboration across diverse teams and stakeholders.

• Experience in process development with miniaturized bioreactor systems, in particular ambr15 and ambr250, as well as shake flask systems
• Knowledge of cell banking (generation, qualification, and storage of MCB/WCB) in accordance with ICH and GMP guidelines
• Industry background from a CDMO, pharmaceutical company, or comparable commercial environment
• Knowledge of the application and development of analytical methods (in particular: qPCR, dPCR, Southern blot, N-glycan analysis (RFMS), HP-SEC, CEX, cIEF, CE-SDS, binding assays, etc.) for cell line and protein characterization

Personal Competencies

• Strong sense of responsibility and an independent, structured way of working
• Excellent teamwork and communication skills - at both the staff and management level
• Proactive, solution-oriented working style with strong analytical thinking
• Quick comprehension and the ability to set priorities in a dynamic environment
• High level of self-motivation, commitment, and a hands-on mentality
• Very good analytical thinking and confident scientific decision-making
• Accurate, quality-conscious working style with an eye for detail
• Enjoyment of developing team members professionally and fostering a constructive team culture

• A responsible leadership role in an innovative biopharmaceutical company
• The opportunity to actively help shape modern cell line development technologies
• Flat hierarchies, short decision-making paths, and a collegial working environment
• Individual training and development opportunities
• Room for professional and personal growth, and the chance to actively shape processes, structures, and team capabilities
• Attractive, performance-based compensation and modern laboratory equipment
• Flexible working hours and the option of remote working by arrangement