Overview
Teamleader Process Development Downstream (Munich)
Your role
- leading and developing a growing team in DSP process and formulation development
- design and development of downstream processes from laboratory to production scale
- definition of process risks and development of process validation strategy in process validation in collaboration with the CMC manufacturing team and external CMOs
- managing process failures, defining investigation strategies and performing the required experiments
- formulation development to ensure product stability and improve the shelf life of the product
- collaboration with technology development, USP process development, process analytics, CMC and QC
- timely creation and review of development and qualification protocols
- creation of relevant chapters for CMC dossiers
- collaboration in project and core teams to ensure the overall flow of information between sites
Your profile
- proven leadership and planning skills
- PhD or relevant experience in gene / cell therapy or biopharmaceuticals
- 5 years of active experience in DSP process development
- expertise in scale-up processes from laboratory to production scale
- experience in technology transfer
- proven competence in protein analysis and formulation development
- teamwork and flexibility
- very good german or english spoken and written
Your next step
If you are interested in learning more about this role, I look forward to hear from you. Your contact for this position is Maximilian Rudek (Senior Consultant Pharma).
Please send me your current CV via e-mail to rudek@ageneo.de or contact me by phone on 089 726321008.
