Jessica braeun

QA representative in cross functional development programs Establishing and implementation of phase appropriate QMS within Affimed as a virtual company Provision of training to personnel and establishment of quality culture program, self-inspection and continuous improvement approaches Third Party Management including vendor (re-) qualification, audits and negotiation of Quality Agreements PAI readiness initiatives with third party vendors Quality Control and Manufacturing requirements on sponsor site

Global Quality Systems & Services with focus on the companies global Quality Management System

• Change Control Coordinator Warner Chilcott sites and products • Development & Implementation of Global Quality Management System Actavis/Warner Chilcott

Change Control Coordinator Abbott Established Product Division

• Biotechnological Products, e.g. recombinant antibodies • Analytical Method Validation and Qualification • Managing stability studies of parenteral drug products (Phase II to III) • Analytical release and stab testing clinical material

Thesis: Division of Experimental Orthopaedics, Orthopaedic Clinic, University of Heidelberg, Germany; Title: Construction and expression analysis of C-terminal modified CRTAC1A-Proteins: Secretion is independent of the use of the last exon. (in German)