Robert E. Zoubek

Principal Consultant
Granzer Regulatory Consulting & Services, Germany
Robert has 20 years of experience in development of biologics and gene and cell therapies. His expertise comprises the regulatory requirements for analytical methods, method validation, cell bank establishment, product and process development and actual manufacture. . Robert is Principal Consultant at Granzer Regulatory Consulting & Services and supports clients worldwide on CMC from early development up to marketing authorization for Europe and USA. Until he joined Granzer, Robert worked in several positions at the Formycon/Germany, a leading developer of Biosimilars for regulated markets. As Director Scientific Affairs he led Formycon´s drug product development and analytical services. Before that, Robert was Head of Protein Characterisation & Preformulation and Manager Quality Operations. In those positions he supervised Formycon´s GMP-Quality Control and analytical labs, the core of Quality-Biosimilar development. Robert earned the PhD from the University of Erlangen-Nuremberg for his research on therapeutic peptides and he was awarded Master of Business Administration from the University of Manchester. He also holds a MSc from the University of Munich.

Events/Masterclasses Robert E. Zoubek is currently speaking at

Pharma

Stability & Shelf Life of Biologics
16 - 18 May 2022
Barcelona, Spain | Online Live Stream 9:00 CEST - 15:00 CEST
The purpose of this Stability & Shelf Life of Biologics Training Course is to get comprehensive overview on stability and shelf-life regulatory landscape.

Pharma

Quality Requirements for Biotech Products
12 - 14 December 2022
Online Live Stream 09:00 CET – 17:30 CET
This practical course provides an in-depth understanding regulatory landscape for national CTA procedures.

Pharma

CMC Analytical Comparability: Methods & Strategies for Biologics
24 - 25 November 2022
Vienna, Austria | Online Live Stream 09:00 CET - 17:30 CET
Join our CMC Analytical Comparability training led by experts to understand principles of protein structure and comparative analytics.

Pharma

Cell & Gene Therapy Products – CMC & Quality Requirements
13 - 15 September 2022
NH Sants Barcelona, Spain | Online Live Stream 09:00 CEST – 15:00 CEST
This unique course provides a practical & in-depth understanding of CMC & quality requirements and brings clarifications on global regulation, requirements, compliance & quality concerns.

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Robert E. Zoubek
Principal Consultant
Granzer Regulatory Consulting & Services, Germany
Robert has 20 years of experience in development of biologics and gene and cell therapies. His expertise comprises the regulatory requirements for analytical methods, method validation, cell bank establishment, product and process development and actual manufacture. . Robert is Principal Consultant at Granzer Regulatory Consulting & Services and supports clients worldwide on CMC from early development up to marketing authorization for Europe and USA. Until he joined Granzer, Robert worked in several positions at the Formycon/Germany, a leading developer of Biosimilars for regulated markets. As Director Scientific Affairs he led Formycon´s drug product development and analytical services. Before that, Robert was Head of Protein Characterisation & Preformulation and Manager Quality Operations. In those positions he supervised Formycon´s GMP-Quality Control and analytical labs, the core of Quality-Biosimilar development. Robert earned the PhD from the University of Erlangen-Nuremberg for his research on therapeutic peptides and he was awarded Master of Business Administration from the University of Manchester. He also holds a MSc from the University of Munich.
Robert E. Zoubek
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