Natural Scientist (Quality Assessment) - Gene and Cell Therapy | Biologe (m/w/d)
Paul-Ehrlich-Institut
Job Summary
This role involves coordinating and processing quality assessment procedures for Advanced Therapy Medicinal Products (ATMPs), focusing on gene and cell therapeutics and coagulation products, within the framework of marketing authorization applications and clinical trials. The successful candidate will advise pharmaceutical companies on technical and regulatory matters concerning ATMP quality and manufacturing, contribute to developing regulatory guidelines, and represent the institute in national and international committees. Key requirements include a Master's degree (or equivalent) in Life or Natural Sciences, knowledge of virology, cell biology, and gene/cell therapy, and experience in immunological and protein biochemical data analysis. This is a demanding, part-time (up to 19.5 hours/week) position within a federal scientific institution responsible for the testing and approval of vaccines and biomedical medicines, offering flexible working hours and the opportunity to engage deeply in cutting-edge life sciences regulation.
Required Skills
Education
Master's degree or comparable in Life or Natural Sciences (e.g., Molecular Biology or Biochemistry); Doctorate (Ph.D.) desirable
Experience
- Knowledge and experience in immunological and protein biochemical data analysis
- Knowledge and/or experience in pharmaceutical drug regulation (advantageous)
- Professional experience in coordinating and processing regulatory assessment procedures
Languages
Additional
- Declaration of Interests required (EMA); Declaration according to § 77a AMG required; Temporary contract (3 years); Part-time position (up to 19.5 hours/week).
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