BioNTech SE
Director GMP Production(m/w/x)
Vollzeit
Keine Angabe
Mainz
BI
BioNTech SE1 Monat
Director Manufacturing Sciences & Technology(m/w/x)
Vollzeit
Senior
Keine Angabe
Mainz
Nejo KI-Zusammenfassung
In this strategic leadership role, you will be the technical voice for RNA and antibody products, ensuring compliance and driving excellence throughout the product lifecycle, from development to post-launch support.
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Anforderungen
- •Advanced degree in Biotechnology, Biochemistry, Chemical Engineering, or related field
- •Extensive experience in late-stage product development, commercial manufacturing, and technical lifecycle management
- •Proven track record in CMC leadership, including technical transfer, regulatory submissions, and post-approval change management
- •Deep understanding of RNA and antibody-based products, control strategies, and regulatory compliance
- •Demonstrated ability to lead cross-functional teams and manage complex technical projects
- •Excellent verbal and written communication skills
- •Strong interpersonal skills and experience managing strategic partnerships with global collaborators
- •Analytical mindset with a proactive approach to identifying and mitigating risks
- •Experience with Biologics License Applications (BLA) and Responses to Questions (RTQs)
- •Familiarity with Good Manufacturing Practices (GMP) and Annual Product Reviews (APRs)
- •Expertise in managing Post-Approval Change Management Plans (PACMP)
Master-Abschluss
Berufserfahrung
ca. 4 – 6 Jahre
Deine Aufgaben
- •Ensure compliance with regulatory dossiers
- •Advocate for technical excellence
- •Develop strategies for technical lifecycle management
- •Lead the Commercial CMC Team
- •Drive late-stage technical transfer
- •Ensure Biologics License Application readiness
- •Oversee Responses to Questions and launch support
- •Manage GMP manufacturing investigations
- •Monitor process performance and Annual Product Reviews
- •Manage Post-Approval Change Management Plans
- •Identify and mitigate product risks
- •Drive technical improvements across the product lifecycle
- •Provide guidance and training to MS&T staff
- •Build strategic alliances with key partners
- •Act as the primary interface for strategic partnerships
- •Support product manufacturing with robust control strategies
- •Lead investigations into GMP manufacturing issues
- •Monitor and analyze product performance
Sprachen
Englisch – verhandlungssicher
Deine Vorteile
Flexibles Arbeiten
- •Flexible hours
Mehr Urlaubstage
- •Vacation account
Weiterbildungsangebote
- •Digital learning
- •Apprenticeships
- •LinkedIn learning
Karriere- und Weiterentwicklung
- •Performance & talent development
- •Leadership development
Sonstige Vorteile
- •Your voice at the table
- •Support for your full potential
Lockere Unternehmenskultur
- •Culture on an equal footing
Sinnstiftende Arbeit
- •Opportunities to shape & impact
Firmenfahrrad
- •Company bike
Öffi Tickets
- •Job ticket
- •Deutschlandticket
Betriebliche Altersvorsorge
- •Employer-funded pension
Kinderbetreuung
- •Childcare
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BioNTech SE erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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