Lörrach, Baden-Württemberg, Germany
In the last years I developed myself from a scientific driven bench scientist to a project expert in a GMP environment with the knowledge of underlying scientific mechanisms. I never lost the laboratory skills what makes me an ideal connector between lab processes and the more theoretical project management.
Development, validation and clinical sample analysis in PK, PD and IG assays
Analytical Expert Role: • Planning and management of pre-clinical and clinical GMP bioassay activities for the Novartis biologics pipeline (releases, stabilities, method validation) for a timely delivery of results • Managing interactions of internal and external stakeholders (outsourcing, assay transfer) • Lab management, sample management, equipment system owner including guidance to laboratory associates • Authoring and reviewing of SOPs, analytical procedures, reports, equipment changes Lab Analyst Role: • Assay validation and routine bioassay analysis (release, stabilities; cell-based assays, ELISA) under GMP; train other lab analysts
• Development, optimization, transfer of bioassays as well as routine analysis from pre-clinical up to phase III (cell based assays, ELISA, process-related high molecular weight impurities) for the Novartis biologics pipeline, including experimental planning, data analysis and interpretation as well as documentation in a non-GMP environment • Assay validation and routine analysis (release, stabilities) under GMP • Lab management including equipment responsibilities • Authoring and reviewing of protocols, analytical procedures, reports, SOPs Publication: Fabian Bickel, François Griaud, Wolfram Kern, Frieder Kroener, Manuela Gritsch, Jérôme Dayer, Samuel Barteau, Blandine Denefeld, Chi-Ya Kao-Scharf, Manuel Lang, Izabela Slupska-Muanza, Carla Schmidt, Matthias Berg, Jürgen Sigg, Lina Boado, Dirk Chelius: Restoring the biological activity of crizanlizumab at physiological conditions through a pH-dependent aspartic acid isomerization reaction MAbs. 2023 Jan-Dec;15(1):2151075
• Development and performance of cell based in vitro bioassays e.g. ADCC, CDC, whole blood assay, FACS-based binding assays for the characterisation of antibody-based product candidates including experimental planning, data analysis and interpretation as well as documentation • Responsibility for laboratory equipment Publication: Ekkehard Mössner, Peter Brünker, Samuel Moser, Ursula Püntener, Carla Schmidt, Sylvia Herter, Roger Grau, Christian Gerdes, Adam Nopora, Erwin van Puijenbroek, Claudia Ferrara, Peter Sondermann, Christiane Jäger, Pamela Strein, Georg Fertig, Thomas Friess, Christine Schüll, Sabine Bauer, Joseph Dal Porto, Christopher Del Nagro, Karim Dabbagh, Martin J S Dyer, Sibrand Poppema, Christian Klein, Pablo Umaña: Increasing the efficacy of CD20 antibody therapy through the engineering of a new type II anti-CD20 antibody with enhanced direct and immune effector cell-mediated B-cell cytotoxicity Blood. 2010 Jun 3;115(22):4393-402.
• Project management (planning, laboratory work, data analysis, documentation, publication of results) • Organisation of the laboratory routine work, training of colleagues, student lectures, grant acquisition • Main methodological experience: cell culture of primary cells, quantitative PCR, scanning electron microscopy, ELISA Publications: Kreja L, Liedert A, Schmidt C, Claes L, Ignatius A Influence of RANKL, M-CSF and FCS on human osteoclast formation and activity. J Mol Histol. 2007 Aug;38(4):341-5. Erratum corrected in: J Mol Histol. 2007 Oct;38(5):341-5 Kaspar D, Hedrich CM, Schmidt C, Liedert A, Claes LE, Ignatius AA Diclofenac inhibits proliferation and matrix formation of osteoblast cells Unfallchirurg. 2005 Jan;108(1):18, 20-4 Neidlinger-Wilke C, Würtz K, Liedert A, Schmidt C, Börm W, Ignatius A, Wilke HJ, Claes L A three-dimensional collagen matrix as a suitable culture system for the comparison of cyclic strain and hydrostatic pressure effects on intervertebral disc cells. J Neurosurg Spine. 2005 Apr;2(4):457-65 Ignatius A, Blessing H, Liedert A, Schmidt C, Neidlinger-Wilke C, Kaspar D, Friemert B, Claes L Tissue engineering of bone: effects of mechanical strain on osteoblastic cells in type I collagen matrices. Biomaterials. 2005 Jan;26(3):311-8 Schmidt C, Steinbach G, Decking R, Claes LE, Ignatius AA IL-6 and PGE2 release by human osteoblasts on implant materials. Biomaterials. 2003 Oct;24(23):4191-6 Schmidt C, Kaspar D, Sarkar MR, Claes LE, Ignatius AA A scanning electron microscopy study of human osteoblast morphology on five orthopedic metals. J Biomed Mater Res. 2002;63(3):252-61 Ignatius AA, Schmidt C, Kaspar D, Claes LE In vitro biocompatibility of resorbable experimental glass ceramics for bone substitutes. J Biomed Mater Res. 2001 Jun 5;55(3):285-94 Schmidt C, Ignatius AA, Claes LE Proliferation and differentiation parameters of human osteoblasts on titanium and steel surfaces. J Biomed Mater Res. 2001 Feb;54(2):209-15