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.