BioNTech SE
Analytical Method Expert (Associate Director AS&T Lifecycle Management)(m/w/x)
Vollzeitnur vor OrtSenior
Mainz
Neuer Job?Nejo!
Die KI-Suchmaschine für Jobs
BIBioNTech SE
Director AS&T Projects & Strategy(m/w/x)
Mainz
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading analytical project strategy for antibody development across interdisciplinary teams. 10+ years biotech/pharma industry experience, strong analytical CMC background required. Flexible hours, vacation account.
Anforderungen
- Advanced university degree in scientific discipline (Biology, Chemistry, Pharmacy, Biotechnology, or comparable)
- Optional PhD or equivalent qualification
- Industry experience (10+ years) within biotech or pharmaceutical industry
- Strong background in analytical CMC activities for mAbs and/or work experience in mAb QC and/or analytical development
- Proven track record in analytical late-stage antibody development
- Ideally including antibody-drug conjugates (ADCs)
- Demonstrated leadership experience
- Analytical project management experience
- Profound knowledge of relevant US and EU regulatory standards
- Profound knowledge of EMA regulatory standards
- Profound knowledge of FDA regulatory standards
- Profound knowledge of CMC analytical development packages
- Profound knowledge of Good Manufacturing Practices
- Profound knowledge of USP (United States Pharmacopoeia)
- Profound knowledge of Ph. Eur. (European Pharmacopoeia)
- Experience with pre-approval activities (PAI, BLA preparation, launch activities) (plus)
- Fluent English
- Technical writing skills
- Experience in intercultural, cross-functional teams
- Structured way of working
- Ability to understand and break down complex challenges
- Ability to plan associated timelines and interdependencies
- High motivation
- Willingness to work in fast-paced, fast-evolving environment
Aufgaben
- Represent analytics in interdisciplinary teams.
- Liaise with the CMC team and stakeholders.
- Manage all analytical activities successfully.
- Report progress, delays, and risks to stakeholders.
- Coordinate analytical tasks across internal and external networks.
- Ensure alignment with the overall analytical strategy.
- Define the analytical control strategy across departments.
- Align the analytical control strategy across departments.
- Ensure strategy aligns with guidelines and requirements.
- Author the analytical CMC Module 3 package.
- Review the analytical CMC Module 3 package.
- Manage the Module 3 package lifecycle.
Berufserfahrung
- 10 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- mAbs
- mAb QC
- ADCs
- EMA
- FDA
- USP
- Ph. Eur.
- PAI
- BLA
Benefits
Flexibles Arbeiten
- Flexible hours
Mehr Urlaubstage
- Vacation account
Weiterbildungsangebote
- Digital learning
- LinkedIn Learning
Karriere- und Weiterentwicklung
- Performance and talent development
- Leadership development
Sonstige Vorteile
- Apprenticeships
- Support for full potential
Startup-Atmosphäre
- Voice at the table
Lockere Unternehmenskultur
- Culture on equal footing
Sinnstiftende Arbeit
- Opportunities to shape and 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.
Noch nicht perfekt?
- BioNTech SE
Director Manufacturing Sciences & Technology(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Senior Director Protein Modality Lead(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
(Associate) Director Protein & ADC Drug Product(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München - BioNTech SE
Director Translational Sciences (Oncology)(m/w/x)
Vollzeitnur vor OrtSeniorMainz
BIBioNTech SE
Director AS&T Projects & Strategy(m/w/x)
Mainz
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading analytical project strategy for antibody development across interdisciplinary teams. 10+ years biotech/pharma industry experience, strong analytical CMC background required. Flexible hours, vacation account.
Anforderungen
- Advanced university degree in scientific discipline (Biology, Chemistry, Pharmacy, Biotechnology, or comparable)
- Optional PhD or equivalent qualification
- Industry experience (10+ years) within biotech or pharmaceutical industry
- Strong background in analytical CMC activities for mAbs and/or work experience in mAb QC and/or analytical development
- Proven track record in analytical late-stage antibody development
- Ideally including antibody-drug conjugates (ADCs)
- Demonstrated leadership experience
- Analytical project management experience
- Profound knowledge of relevant US and EU regulatory standards
- Profound knowledge of EMA regulatory standards
- Profound knowledge of FDA regulatory standards
- Profound knowledge of CMC analytical development packages
- Profound knowledge of Good Manufacturing Practices
- Profound knowledge of USP (United States Pharmacopoeia)
- Profound knowledge of Ph. Eur. (European Pharmacopoeia)
- Experience with pre-approval activities (PAI, BLA preparation, launch activities) (plus)
- Fluent English
- Technical writing skills
- Experience in intercultural, cross-functional teams
- Structured way of working
- Ability to understand and break down complex challenges
- Ability to plan associated timelines and interdependencies
- High motivation
- Willingness to work in fast-paced, fast-evolving environment
Aufgaben
- Represent analytics in interdisciplinary teams.
- Liaise with the CMC team and stakeholders.
- Manage all analytical activities successfully.
- Report progress, delays, and risks to stakeholders.
- Coordinate analytical tasks across internal and external networks.
- Ensure alignment with the overall analytical strategy.
- Define the analytical control strategy across departments.
- Align the analytical control strategy across departments.
- Ensure strategy aligns with guidelines and requirements.
- Author the analytical CMC Module 3 package.
- Review the analytical CMC Module 3 package.
- Manage the Module 3 package lifecycle.
Berufserfahrung
- 10 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- mAbs
- mAb QC
- ADCs
- EMA
- FDA
- USP
- Ph. Eur.
- PAI
- BLA
Benefits
Flexibles Arbeiten
- Flexible hours
Mehr Urlaubstage
- Vacation account
Weiterbildungsangebote
- Digital learning
- LinkedIn Learning
Karriere- und Weiterentwicklung
- Performance and talent development
- Leadership development
Sonstige Vorteile
- Apprenticeships
- Support for full potential
Startup-Atmosphäre
- Voice at the table
Lockere Unternehmenskultur
- Culture on equal footing
Sinnstiftende Arbeit
- Opportunities to shape and 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
Analytical Method Expert (Associate Director AS&T Lifecycle Management)(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Director Manufacturing Sciences & Technology(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Senior Director Protein Modality Lead(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
(Associate) Director Protein & ADC Drug Product(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München - BioNTech SE
Director Translational Sciences (Oncology)(m/w/x)
Vollzeitnur vor OrtSeniorMainz