Head Technical Cmc
vor 17 Stunden
Unser Kunde
Noema Pharma ist ein in der Schweiz ansässiges Unternehmen, das sich auf die Entwicklung von Medikamenten gegen seltene ZNS-Erkrankungen spezialisiert hat. Das Unternehmen verfügt über eine umfangreiche Pipeline von Produkten, die von Roche einlizenziert wurden und sich durch ein starkes Sicherheitspaket auszeichnen. Dazu gehört das Hauptprodukt NOE-101, ein mGluR5-Hemmer, der sich in der Phase 2b zur Behandlung von anhaltenden Anfällen bei Tuberöser Sklerose Complex (TSC) und starken Schmerzen bei Trigeminusneuralgie (TN) befindet. NOE-105, ein PDE10A-Hemmer, befindet sich in Phase 2 für die Behandlung des Tourette-Syndroms. Noema Pharma konnte Ende 2020 eine Series-A Finanzierung in Höhe von 54 Mio. CHF erfolgreich abschliessen und wird nun seine klinische Entwicklung weiter vorantreiben. Für den weiteren Ausbau des Teams suchen wir nun einen Head technical CMC & Supply (m/w)
Aufgaben
- Gesamtverantwortung für alle Drug Substance und Drug Product Aktivitäten von der prä-klinik bis zu den klinischen Phasen, inklusive clinical supplies.
- Suche und Auswahl von möglichen CDMOs und CMOs für die Herstellung der Drug Substance und Drug Products
- Begleitung des Technologietransfers der chemischen Prozesse und der Analytischen Methoden
- Supply und Demand Planning, um die klinischen Studien zu unterstützen.
- Support bei der galenischen Formulierungsentwicklung und Erstellen des klinischen Entwicklungsprograms
- Erstellen der relevanten CMC Dokumentationen für die IND und IMPD Anträge und Ansprechpartner gegenüber Europäischen und US Behörden.
Qualifikation
- Abgeschlossenes PhD Studium in Chemie, Pharmazie oder Pharmazeutischer Technologie
- Langjährige Erfahrung im CMC Umfeld, insbesondere im Management von CDMOs und CMOs, Technologietransfers
- Mindestens 8 Jahre Erfahrung in der klinischen Entwicklung neuer Medikamente
- Erfolgreicher Leistungsnachweise in der Drug Product Entwicklung entlang der klinischen Phasen I bis III
- Erfahrung in der organischen Synthese, Know-how in der galenischen Formulieurngsentwicklung ist ein Plus.
- Gutes Know-how im technical Regulatory Affairs, Erstellen der IND und IMPD Anträge
- Hilfsbereiter Teamplayer, derin einem dynamischen und flexiblen Umfeld arbeitet
- Sehr gute Englischkenntnisse sind selbstverständlich
**Benefits**:
- Eine spannende und verantwortungsvolle Tätigkeit in einem jungen Biotech mit starker Pipeline
- Zusammenarbeit mit einem Team aus erfahrenen Branchenexperten und führenden Persönlichkeiten auf ihrem Gebiet
- Sehr gute finanzielle Ausgangslage für die weitere Entwicklung des Unternehmens
Art der Stelle: Vollzeit
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