Senior Consultant Life Sciences

1/2022 – offen

• Leading 3 projects as part of a large-scale internalization project for several vaccine production lines
o Creation of an overview and risk evaluation of >50 single-use components about regulatory and data situation (Extractable & Leachable). Depending on the data situation: Initiate further studies
o Coordination of 5 prototype-tests as part of the internalization strategy for single-use systems. Manage a team of 4-5 members to plan, conduct, document and evaluate the tests
o Risk evaluation by preparing 3 Failure mode and effects analyses (FMEA) with subsequent approval and qualification (URS/DQ/IQ/OQ) of several single-use systems (creation and approval of ~30 qualification documents), ensuring compliance with current GMP standards (USP and EP)

• Project Management Office (PMO) role for the implementation of SAP
o Monitoring and maintaining project plans of a core team of approximately 30 members

• Digitalization Project at MedTech companies

Aufseher, Good Manufacturing Practices, Projektmanagement

11/2020 – 1/2021

• Optimization of the steric exclusion chromatography for the lentivirus purification
using single-use membranes
• Performing assays for virus, protein and DNA determination
• Performing Design of Experiments (DOE) analysis to accelerate development
• Lentivirus production via mammalian cells in single-use bioreactors

Forschung & Entwicklung, Pharmazie, Biotechnologie

2/2019 – 3/2019

• SOP creation about cleaning validation of manufacturing equipment for the production of oncolytic antibodies considering GMP compliance
• Statistical analysis of raw data from filling devices of the diabetes manufacturing site
• Support in the creation of Failure mode and effects analysis (FMEA) of process equipment in terms of switching to single-use parts under consideration of GMP compliance.

Compliance-Beauftragter, Statistiken