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    Produktmanager Biotech Operations (m/w/d)

    from: 18.02.2022
    medac is a dynamic company that has been growing continuously for over fifty years. More than 2,000 employees work on the further development of medical products and medical devices for the diagnosis and treatment of oncological, urological and autoimmune diseases. We are one of the leading pharmaceutical companies, in particular in the field of niche products.
    • Planung und Koordination sowie Durchführung medac-interner Projekte für Biopharmazeutika in der Lohnfertigung
    • Begleitung der Routineproduktionen sowie Durchführung von Validierungen und Produktionstransfers bei Lohnherstellern
    • pharmazeutisch-technische Abweichungsbewertungen aus Routineproduktionen (DEV, CAPA)
    • Erstellung, Aktualisierung und Überwachung von qualitätsrelevanten Dokumenten zur Lohnherstellung (GMP-Dokumentation, Change Control, PQR) und Sicherstellung internationaler, arzneimittelrechtlicher Vorgaben
    • Reisetätigkeiten zur Begleitung von Tätigkeiten bei externen Lohnherstellern

    • Erfolgreich abgeschlossenes, pharmazeutisches oder naturwissenschaftliches Studium insbesondere der Biotechnologie, Biochemie und Biopharmazie
    • Mehrjährige Erfahrungen in der Produktion und/oder Entwicklung von Biopharmzeutika und Drug Device Components, sowie Erfahrungen in der aseptischen Fertigung von Parenteralia und Lyophylisation
    • Kenntnisse in einschlägigen Regularien zu EU/GMP Leitfaden, ATMP Guideline, CFR part 201 und 211
    • Sehr gute Deutsch- und EDV-Kenntnisse, verhandlungssichere Englischkenntnisse
    • Reisebereitschaft (ca. 20%), Teamgeist, Eigeninitiative und Verhandlungsgeschick

    • Your work-life balance is important to us. We offer flexible working conditions with the option of working up to 60% of your hours remotely, 30 annual vacation days and an excellent cafeteria
    • Attractive salaries and success-based bonuses for all medac employees
    • Individual training opportunities: Our medac academy offers a wide range of programmes including leadership training, coaching essentials and language classes
    • A funded pension scheme and other social benefits
    • We care for our employees beyond the workplace and provide advice on caring for elderly relatives as well as offering counselling and childcare
    • We promote sports and activities to improve our employees’ health

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