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Engineer Process Development (m/w/d)
- Gräfelfing, Bavaria, Germany
- Gräfelfing, Bavaria, Germany
About
Neovii Biotech ist Spezialist für die Entwicklung und Vermarktung von immunologisch wirksamen biopharmazeutischen Produkten zur Prophylaxe oder Therapie immunologischer Erkrankungen. Der Schwerpunkt liegt auf dem Einsatz innovativer Antikörpertherapien. Neovii Biotech produziert und vermarktet insbesondere einen polyklonalen Antikörper, der in der Transplantationsmedizin etabliert und weltweit mehr als 40 Ländern zugelassen ist.
Wir suchen zum nächstmöglichen Zeitpunkt einen
Engineer Process Development (m/w/d)
- Modernisierung und Optimierung ausgewählter Herstellprozesse im Bereich ATG
- Durchführung von Risikoanalysen sowie Entwicklung effizienter Prozessdesigns
- Erstellung von Kostenabschätzungen (CAPEX und Herstellkosten)
- Planung, Durchführung und Dokumentation von Entwicklungsaktivitäten für Unit Operations
- Durchführung von Machbarkeits- und Optimierungsexperimenten in verschiedenen Maßstäben
- Enge Zusammenarbeit mit Produktion, Technik, Qualifizierung und Projektteams
- Unterstützung regulatorischer Aktivitäten und Behördeninteraktionen
- Verantwortung für Projektplanung, Reporting, Budget und Timeline-Management
- Abgeschlossenes Studium im Bereich Biotechnologie, Ingenieurwesen oder Naturwissenschaften
- Erfahrung in der Entwicklung und/oder Produktion biologischer Arzneimittel im GMP-Umfeld
- Kenntnisse in Proteinaufreinigung sowie gängigen Unit Operations wie Filtration, Chromatografie, Zentrifugation, Mischen und Wärme-/Kältetransfer
- Sicherer Umgang mit MS Office, insbesondere MS Project, Excel und datenbankgestützter Gerätesoftware
- Strukturierte, proaktive und pragmatische Arbeitsweise mit hoher Eigeninitiative
- Ausgeprägte Team- und Kommunikationsfähigkeit sowie Verständnis für Anforderungen der späteren Routineproduktion
- Sehr gute Deutsch- (CEF C1) und gute Englischkenntnisse (CEF B2)
Bei uns erwartet Sie ein abwechslungsreiches Arbeitsumfeld im Rahmen des Chemietarifvertrags. Flexible Arbeitszeiten (Gleitzeitmodelle, 37,5 Stunden/Woche, Home-Office-Tage), eine attraktive Vergütung, 30 Urlaubstage sowie verschiedene zusätzliche Leistungen (wie z. B. Wellpass-Mitgliedschaft) runden das Angebot ab.
Languages
- German
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