Mühltal, Hesse, Germany
Digitalization Expert • QC methods digitalization/ Labware7 & Labware8 • Direct and SDMS equipment parsing • LabX • CMV Quality Manager • Certification as a project and quality manager (QMB 2014-2017) and as a biological safety officer (for BS level 2) • cGMP-rules, SOP’s , EU-GMP, ISO 13485, ISO9000ff Standards • CAPA Process Optimization • Vaccine Dossiers Compliance • Risk Management • Deviation, CAPA and Change Management Systems • Process Mapping for Validation • Row Material Excellence • Ph.Eur. and USP requirements for RMs • Medical Device Regulations 2017/745 Project Manager and Coordinator • Prince 2 Certification • Coordination of 21 R&D Projects between Biotechnology Company, In-Licensing Partners and external Manufacturers • Involment in process "Transfer to manufacturing " • International project lead "Vaccine media" in-licensing • Coordination of PMO documentation and internal/external ecscalations • Principal contact for external manufacturer and customers issue resolution with manufacturer • Coworking with product management and marketing • Involment in contract negotiations with cooperation partners • Controlling • CMO Excellence Project lead Professional Scientist • Expert in cancer research, biomarker identification, biochemistry, protein science, cellular and molecular biology (more as 10 years of experience) • Adept skills in analytical technologies and establishment of analytical methods • Professional in molecular biology and immunology methodology (Western blotting, IF, FACS, ChIP, IP) as well as in DNA-, RNA- & Protein chemistry and purification (LC, SPR, FRET, FRAP) • Establishment of cell-based models for small-molecule inhibitors, apoptose assays and single cell imaging • Genetic engineering of mammalian cell lines (siRNA and Virus-based (Lenti-, Retro-, Adenovirus) techniques) I like to act as a coordinator and networker. Deep knowledge of digitalization, quality and project management tools and methods qualified me for working in industrial field. Actions as Health and Wellbeing Champion at GSK. My innovative ideas I am realizing by developing business plans, organizing and leading groups.
Beschäftigungsort: Sanofi Aventis Deutschland GmbH/ Höchst
Konzipierung, Organisation und Leitung der Kurse "Bewegung und Entspannung" für verschiedene Interessentengruppen (Eltern mit Babys, Schwangere und alle, die Entspannung lernen möchten).
Methoden Digitalisierung in der QC Labware 8/ LES/ SAP/ LabX/ SDMS/ Empower Health & Wellbeing Champion
Digital Transformation QC Methoden; Labware 7; Business Development
CAPA Prozess Optimierung ISO9001, ISO13485 CAPA Management und Backlog Aufarbeitung Vorbereitung und Teilnahme während des externen Audits Datenbankerstellung und Dokumentation Prozessvalidierung Event Management/ Projektleiterin CMO/ internes Business Development
Gap Analyse & Risikobewertung der Vakzine Zulassungsdokumentation Rohstoff Compliance nach PhEur und USP SOPs-Erstellung Erfahrung in CAPA und Change Management, cGMP, CMO