Job Opportunities API

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 membe