Dr. Robert Zoubek
Angestellt, Executive Consultant, Granzer Regulatory Consulting & Services
München, Deutschland
Werdegang
Berufserfahrung von Robert Zoubek
Bis heute 1 Jahr und 10 Monate, seit Aug. 2022
Executive Consultant
Granzer Regulatory Consulting & Services
Recognized expert for quality requirements of Gene and Cell Therapy products. Geographic areas: EU and US. Development stages: from early development, clinical development, BLA/ MAA. Product classes: mRNA and LNP, DNA vector, Lentivirus, AAV, Retrovirus, Herpesvirus, HIV-based vector, CAR-T, iPSC, gene editing, CRISP, CAS, and many others.
Bis heute 10 Jahre und 8 Monate, seit Okt. 2013
Senior Consultant
Granzer Regulatory Consulting & Services
Regulatory Strategy on Drug Development and Devices & Diagnostics Regulatory Procedures Authority Meetings Electronic Submissions Project Management
8 Monate, Dez. 2021 - Juli 2022
Principal Consultant
Granzer Regulatory Consulting & Services
1 Jahr und 7 Monate, März 2012 - Sep. 2013
Director Scientific Affairs
Formycon
Drug development strategies for Innovators and Biosimilars Research on issues of pharmaceutical drug development (aggregation, charge &hydrophobic heterogeneity, immunogenicity etc.) Evaluation and implementation of innovative technogies and processes. Development of interdisciplinary research programs between industry and academics. Clients´ contact for drug development strategies with regard to regulatory and operational aspects.
11 Monate, Mai 2011 - März 2012
Head of Protein Characterization and Preformulation
Formycon (formerly Scil Technology)
**GMP-Analytics and Quality Control / **Stability studies and compatibility testings / **Protein characterisation and comparability studies / **Team, project and cost center management / **Scientific and disciplinary responsibility for 6 employees / **Employee and Lab development / Business strategies and positioning. Customer acquisition.
1 Jahr und 11 Monate, Juli 2009 - Mai 2011
Manager Quality Operations
Scil Technology GmbH
Method band width: SEC; RPC; HILIC; IEC; PAGE; IEF; Microscope; Turbidimetry; ELISA; Western blot; Light obscuration; AF4-MALLS; SLS; DLS; LC-MS; BioLayer Interferometry; FT-IR; DSC; DSF; CE **GMP-Analytics and Quality Control / **Stability studies and compatibility testings / **Protein characterisation and comparability studies / **Team and project management / **Scientific and disciplinary responsibility for 3 employees / **Employee and Lab development /
1 Jahr und 1 Monat, Juli 2008 - Juli 2009
Research Scientist
GlycoForm
**Protein expression and Purification / **Refolding and Formulation / **Chemical modification and Analytics
2 Jahre und 2 Monate, Mai 2006 - Juni 2008
Post Doc
Universität Erlangen
PostDoc Development of analytical methods for quality control pharmaceutical peptide FDA acceptable bioassays corporation with US Pharma company
Ausbildung von Robert Zoubek
2 Jahre und 1 Monat, Sep. 2010 - Sep. 2012
Master of Business Administration
Manchester Business School
Management
6 Jahre und 4 Monate, Apr. 2002 - Juli 2008
Biochemie
FAU Erlangen-Nürnberg
Purification, characterization and engineering of pharmazeutically active peptides. Tissue regeneration, wound healing, neo-vascularization.
6 Jahre und 3 Monate, Okt. 1995 - Dez. 2001
Biologie
LMU München
Enzyme kinetics, protein biochemistry, cell biology, cancer research, apoptosis
Sprachen
Deutsch
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Englisch
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Italienisch
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