Natural Scientist (Immunology Quality Assessment) | Biologe (m/w/d)
Paul-Ehrlich-Institut
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
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.
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