We are a growth-oriented biopharmaceutical company focused on the development and manufacture of biologic drugs. To strengthen our Cell Line Development team, we are looking for a committed leader, effective immediately, to actively help shape our processes and provide technical and strategic leadership for our team. ## **Your Responsibilities** - **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 ## **Your Profile** ***Required Qualifications*** - **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. ***Preferred Qualifications*** - **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 ## **What We Offer** - 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 ## **Your Application** We look forward to receiving your complete application (cover letter, CV, relevant references), including your earliest possible start date. Please submit your documents through our online portal. *We welcome applications from all individuals, regardless of gender, age, background, or disability.*