more about …

Joern Steiger

During his career, he achieved the following diplomas and awards:

  • GMP Compliance Manager

  • Aseptic Production Manager

  • Qualified Person

  • Official Representative of the University of Dalian for Dendritic Cell Vaccines

Professional Experience

Ad Potius GmbH, Germany
Managing Director (2023 - Present)

  • Spearheaded the Oncological Concept Clinic (OKK) pilot project, enhancing patient care and treatment outcomes.

RARSIG MEDICAL TEAM GmbH, Germany & China
Consultant (2021 - Present)

  • Provided expert guidance on GMP-compliant laboratory planning and quality management development for immunotherapeutics.

Ad Lentus Laboratories GmbH, Germany
Managing Director (2014 - 2021)

  • Directed project planning and development, significantly improving operational efficiency and product quality.

Animal Immune Company, France
General Manager (2019 - 2022)

  • Led the development of veterinary medical therapeutics, advancing animal health and welfare.

Swiss BioScience GmbH, Switzerland
Responsible Person (20%) (2015 - 2017)

  • Oversaw research and development of somatic cell therapeutics, enhancing company's product portfolio.

GenMed.care Corp., USA
Consultant (2015 - 2017)

  • Advised on GMP-compliant laboratory planning and QM development for immunotherapeutics, ensuring regulatory compliance.

Steiger Consulting
Owner (2012 - 2015)

  • Provided specialized consulting in GMP, particularly for ATMPs, contributing to several successful regulatory approvals.

Education

Berufsfachschule Dr. von Morgenstern, Braunschweig
State-Certified Biological-Technical Assistant (1989 - 1991)

General Qualification for University Entrance (Abitur) (1986)

Skills

  • Soft Skills: Exceptional leadership and motivational skills in high-pressure environments, adept at project management and team collaboration, with a keen understanding of strategic planning and crisis management.

  • Hard Skills: Expertise in GMP guidelines, aseptic manufacturing, cleanroom systems, quality management systems, validation and qualification, ATMPs, auditing, and regulatory affairs.

  • Languages: Fluent in German and English.

Professional Development

  • Comprehensive experience with regulatory authorities, including submission and compliance processes.

  • In-depth knowledge of AMG, HGM-CH, and GMP-Guidelines Annex 1, 2, & 13.