Downstream Process Transfer Engineer | Biologe (m/w/d)

Job Summary

This role involves acting as a critical expert in the transfer of biopharmaceutical manufacturing processes within a major pharmaceutical company near Biberach. The engineer will be responsible for planning and executing complex transfer projects for both early-stage (CMC I) and late-stage (CMC II) biologicals, with a primary focus on Downstream purification. Key daily tasks include managing product transfer activities for clinical production facilities, creating high-quality transfer documentation (including process descriptions, risk analyses, and facility fit analyses) in compliance with international regulatory guidelines, and preparing regulatory submission documents. The position requires strong leadership skills to manage direct process transfers for external clients (CMB) and to represent the clinical production facility in cross-functional and interdisciplinary teams. Candidates must possess a strong background in Biology or related life sciences, professional experience in biopharmaceutical manufacturing, and fluent proficiency in both German and English.