Natural Scientist (Immunology Quality Assessment) | Biologe (m/w/d)

Paul-Ehrlich-Institut

Langen (Hessen), Hessen, Deutschland
Published Dec 9, 2025
Full-time
No information

Job Summary

This role involves working as a Natural Scientist within the 'Assessment Quality Immunology' division of a federal scientific institution responsible for the approval of vaccines and biomedical drugs. The primary focus is on evaluating the quality and non-clinical aspects of antibody therapeutics, particularly monoclonal antibodies, within national and European authorization procedures and clinical trials. Day-to-day tasks include assessing benefit-risk profiles, manufacturing quality, and testing data for immunoglobulins and antibody-containing products. The specialist will develop scientific expertise, write comprehensive reports, advise pharmaceutical manufacturers on regulatory and scientific matters, and contribute to the development of regulatory guidelines. This position requires a Master's degree in Natural Sciences (e.g., Biology, Chemistry, Pharmacy, Medicine), professional experience in immunology and protein biochemistry, and strong German and English language skills, offering a challenging and interdisciplinary role in a rapidly growing biopharmaceutical sector.

Required Skills

Education

Master's degree or comparable scientific university degree (e.g., Biology, Chemistry, Pharmacy, Medicine); Doctorate desirable

Experience

  • Professional experience and comprehensive knowledge in immunology and protein biochemistry (e.g., in the pharmaceutical industry)
  • Professional experience in drug regulation (e.g., assessing the quality of immunoglobulins and/or antibody-containing products) is advantageous

Languages

German (Fluent)English (Fluent)

Additional

  • Must submit a Declaration of Interests to the EMA and a declaration according to § 77a AMG upon contract signing; Employment is limited to three years.