A day in Bio MS&T Upstream Processing
Your main responsibility will be the transfer of production processes for monoclonal antibodies. You will represent MSAT USP in cross-functional teams, e.g. composed of MS&T, R&D, CMO and commercial operations as a process expert handling implementation at manufacturing scale. This ranges from initial FMEA risk analysis, identification of gaps to the design of mitigation experiments, support in validation activities, person in plant to participation in BLA authoring.
You will be responsible for the design, conduction, documentation and evaluation of SDMs, relevant process improvements, process characterization and comparability studies in shake flasks and reactors from 0.25 L to 10 L scale. Another one will be to develop and qualify scale down models to support commercial manufacturing activities.
To compose and review SOPs’, project plans and reports and to participate actively in equipment qualification tasks and continuous department improvement projects will be a day-to-day business. With your skills in plain statistics as well as MVDA and DoE methods you will help the team to generate scientifically sound results.
Who are we searching for
You are
Self-organized, well-structured and solution oriented, with high affinity to data sorting and analysis
A talented team player with strong social and communicational skills
Able to work within matrix structure and a multi-culture environment
Flexible in following experimental requirements that include weekend work about every 6 weeks
You have
A M.Sc. or PhD in Biotechnology, Biochemistry, Bio Engineering or related disciplines
More than 4 (M.Sc.) or 2 (PhD) years in MSAT / commercial manufacturing / development preferable in the area of mammalian cell culture
Deep technological and scientific understanding of biopharmaceutical cell culture processes
Proven track record as project team member in pharmaceutical project
Excellent command of German and English (spoken and written)
Understanding of GMP requirements especially biopharmaceutical quality and regulatory requirements (EMA and FDA)
Advanced data analysis and programming skills e.g. with MATLAB, Simulink or Python are a plus
