Principal
Michael Brandauer
Biography
Entrepreneurial, innovative leader with extensive cross-functional experience in the highly competitive life science industries. Analytical professional skilled in improving organizational performance. Collaborative communicator continually focused on building relationships and promoting synergy across business lines and global units to drive positive change, cohesive, comprehensive business approaches, and enhanced profitability.
Areas of Expertise include:
▪ Certified Quality Auditor (ASQ CQA) ▪ Tech Transfer | ▪ Up- and Downstream Process Transfer and Harmonization | ▪ Aseptic Process Simulations for a novel vaccine |
▪ Languages: German (native); English (proficient); Russian (basic) | ▪ Tech Transfer of Phase II-III projects, along with established drugs and to new CMOs ▪ Trade License Holder | ▪ GXP Documentation, ISO 9001, ISO 13485 ▪ Staff Training & Leadership |
Software: | ▪ Microsoft Office Suite, OpenOffice | ▪ ERP: SAP Hana, NAVision, GUS |
▪ Quality Management (TrackWise, Master Control, Documentum, SopGuard) | ▪ Spinworks, ChemLab | ▪ Statistics: MiniTab, JMP, QlikView |