Projektleiter Manufacturing Science and Technology

vor 2 Monaten


Muttenz, Schweiz oprandi & partner ag Vollzeit
Lörrach/Visp: Sie fühlen sich im Bereich analytischer Methoden und Validierung sowie Transfer analytischer Methoden in Ihrem Element

Unser Kunde ist ein europaweit tätiges Engineering Unternehmen in der Planung und Realisierung von biotechnologischen, pharmazeutischen und chemischen Projekten im Bereich Produktion, Forschung und Entwicklung, sowie der Planung von Anlagen im Bereich Energie.
Im Rahmen des weiteren Ausbaus des Bereiches Manufacturing Science & Technology (MS&T)-Teams suchen wir eine erfahrene und dynamische Persönlichkeit als

Als Verfahrens-, Chemie-, Pharma- oder Biotechnologie-Ingenieur koordinieren, planen und dokumentieren Sie Methodenentwicklung und Transfers analytischer Methoden in der pharmazeutischen Industrie. Sie überwachen die Planung und Dokumentation von Stabilitätsstudien, Comparability respektive Biosimilarity Studien und führen eine Prozesscharakterisierung durch. Weiter sind Sie massgeblich an der Vorbereitung auf Inspektionen durch die SwissMedic und FDA beteiligt und sind eine Unterstützung der biopharmazeutischen Produktionsvorbereitung und Qualitätssicherung. Die Erstellung und Review von Dokumenten wie Analytische Spezifikationen, Testing Monographen, Validierungs- und Transferdokumenten gehören ebenso in Ihr Aufgabengebiet.

Sie verfügen über eine Ausbildung in den Bereichen analytische Entwicklung Qualitätskontrolle, Biochemie, aseptische Fertigung bzw. Sterilprozesse, Biotechnologie, Bioprozesstechnik, Pharmatechnologie o.ä. und können bereits Berufserfahrung vorweisen. Idealerweise haben Sie Erfahrung in den Gebieten analytische Entwicklung / Qualitätskontrolle (Schwerpunkt Drug Product), Produktion, MS&T und QA. Ebenso sind Sie mit wesentlichen Richtlinien (EU, FDA, ICH, HMG, AMBV etc.) sowie statistischen Methoden mit Sottware Minitab, JMP, SAS oder VBA vertraut.
Sie bringen ausgezeichnete Deutsch- und Englischkenntnisse in Wort und Schrift mit. Sie sind es gewohnt selbstverantwortlich zu arbeiten, sind teamfähig, haben eine professionelle Einstellung und Freude an neuen und wachsenden Herausforderungen.

Sie erwartet eine interessante Herausforderung für die Gestaltung Ihres Verantwortungsbereichs sowie die Chance, sich in einem vielseitigen Unternehmen mit einem motivierten Team fachlich und persönlich weiterzuentwickeln. Ihr Arbeitsort ist Basel oder Visp.

Wenn Sie sich mit den Aufgabenstellungen identifizieren können, freuen wir uns auf Ihre Bewerbung mit dem Vermerk 2413197. Für weitere Auskünfte steht Ihnen Herr Marco Manzetti gerne zur Verfügung.

oprandi & partner ist eine internationale Firmengruppe mit zahlreichen Niederlassungen in Europa und den VAE/Dubai

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