Beschreibung
Glycothera is a specialized CDMO supporting biologics development across cell line development, process development, analytics, and GMP-aligned testing. Operating from integrated sites in Julich and Hanover, Germany, the company works within a unified scientific and quality framework that enables reliable, regulatory-ready CMC execution. With nearly three decades of development experience and long-standing contributions to biologics supported by EMA and FDA approvals, Glycothera partners with bi...
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Glycothera is a specialized CDMO supporting biologics development across cell line development, process development, analytics, and GMP-aligned testing. Operating from integrated sites in Julich and Hanover, Germany, the company works within a unified scientific and quality framework that enables reliable, regulatory-ready CMC execution. With nearly three decades of development experience and long-standing contributions to biologics supported by EMA and FDA approvals, Glycothera partners with biotech and pharmaceutical companies to advance development programs with scientific depth, precision, and consistency.
We are currently looking for a manager to strengthen our R&D capacity at our Jülich site. The role focuses on the generation of regulatory-compliant CHO-K1 cell lines for the production of biopharmaceuticals.
Manager Cell Line Development (m/f/d)
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.
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
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 environ...