BioNTech SE
Director AS&T Projects & Strategy(m/w/x)
Vollzeitnur vor OrtSenior
Mainz
Neuer Job?Nejo!
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BIBioNTech SE
Director Manufacturing Sciences & Technology(m/w/x)
Mainz
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading late-stage technical transfer and CMC strategy for RNA and antibody-based products. Extensive late-stage product development and RNA/antibody product expertise required. Flexible hours, vacation account.
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)
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
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
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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BIBioNTech SE
Director Manufacturing Sciences & Technology(m/w/x)
Mainz
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading late-stage technical transfer and CMC strategy for RNA and antibody-based products. Extensive late-stage product development and RNA/antibody product expertise required. Flexible hours, vacation account.
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)
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
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
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.
Über das Unternehmen
BioNTech SE
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
Noch nicht perfekt?
- BioNTech SE
Director AS&T Projects & Strategy(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Senior Director Protein Modality Lead(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Analytical Method Expert (Associate Director AS&T Lifecycle Management)(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Executive Director Manufacturing Network QA(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Director Process Engineering(m/w/x)
Vollzeitnur vor OrtSeniorMainz