Karin Abitorabi
Angestellt, Head Process Development & Innovation, Minaris Regenerative Medicine GmbH
Weil am Rhein, Deutschland
Werdegang
Berufserfahrung von Karin Abitorabi
Bis heute 3 Jahre und 2 Monate, seit Mai 2021
Head Process Development & Innovation
Minaris Regenerative Medicine GmbH
7 Jahre und 10 Monate, Juni 2013 - März 2021
Senior Fellow Cell and Gene Therapy
Novartis Pharma AG, Basel, Schweiz
2 Jahre und 1 Monat, Juni 2011 - Juni 2013
Consultant
Cell Therapy and Flow Cytometry Consulting (USA and Europe)
Key role in Process Development (PD) efforts and experimental design to achieve FDA compliance (closed system, release assay development etc.) in preparation and support of the CMC (chemistry, manufacturing, and control) section for Pre-IND (investigational new drug) documentation. Training of QC staff in Flow Cytometry (acquisition and analysis) for release and FIO (for information only) phenotypic acquisition and analysis. Development of Flow Cytometry panels Close collaboration with QA and CMO
11 Monate, Aug. 2010 - Juni 2011
Senior Scientist
Progenitor Cell Therapy, Mountain View, California, USA
*Responsible for overall management and success of projects in Process Development Department. • 2 Direct Reports and close interactions with other departments (QA/QC/Manufacturing) on the East and West Coast • Active support of GMP manufacturing and client interactions to support phase I/II clinical trials • Active participation in writing and costing of contracts and proposals • Excellent written and oral communication skills evidenced by reports, BPR, SOPs, PD documents
10 Monate, Okt. 2009 - Juli 2010
Interim Day-to-Day Operations Manager of the Mountain View Facility
Progenitor Cell Therapy, Mountain View, California, USA
11 Direct Reports from Manufacturing and Process Development Departments, reported to VP of Manufacturing • Responsible and Organized day-to-day operations for GMP manufacturing • Supervised GMP Manufacturing and Process Development personnel and activities for 5-6 different national and international client projects
1 Jahr und 3 Monate, Aug. 2008 - Okt. 2009
Senior Scientist Process Development
Progenitor Cell Therapy, Mountain View, California, USA
*Project Management of multiple cell-based studies in parallel with national and international clients *Development of closed systems to bridge gap between Research and GMP manufacturing for clinical trials *Main Focus: Primary cells (autologous and allogeneic) for Cell Therapy applications *Technical transfer of client assays and generation of standard operating procedures (SOPs) and batch production records (BPR)
1 Jahr und 8 Monate, Jan. 2007 - Aug. 2008
Development Scientist
Progenitor Cell Therapy, Mountain View, California, USA,
3 Jahre und 10 Monate, Apr. 2003 - Jan. 2007
Scientist II
Schering Plough Biopharma (formerly DNAX Res. Inst.), Palo Alto, California, USA
2 Jahre und 2 Monate, Jan. 2001 - Feb. 2003
Senior Research Associate
Cell Genesys, Inc., Foster City, California, USA
5 Jahre und 10 Monate, Okt. 1994 - Juli 2000
Scientist
SyStemix, Inc., Palo Alto, California, USA
Ausbildung von Karin Abitorabi
1989 - 1994
Microbiology and Immunology
Universität Konstanz
Sprachen
Englisch
Fließend
Deutsch
Muttersprache
Französisch
Fließend
Spanisch
Grundlagen