AbbVie
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
Vollzeitnur vor OrtSenior
Ludwigshafen am Rhein
Neuer Job?Nejo!
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ABAbbVie
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
Ludwigshafen am Rhein
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
You will drive the pharmaceutical development of biological drug products by leading global strategy teams and coordinating cross-functional experts to deliver innovative, patient-centric solutions.
Anforderungen
- BS, Master's, PhD, or equivalent qualification
- Experience in formulation, manufacturing, or analytical development
- Bachelor's, Master's, or PhD in science
- Knowledge in Biologics drug product development
- Established expert in specific technical area
- Understanding of ICH, EMA, FDA regulations
- Experience with novel modality projects
- Excellent communication and stakeholder management skills
- Interpersonal skills and matrix environment leadership
- Structured, proactive, and reliable working style
- Comfort with ambiguity and risk-based decision-making
Aufgaben
- Lead biologics drug product development on global strategy teams
- Act as the primary contact for drug product topics
- Develop formulations, manufacturing processes, and container closure systems
- Collaborate with cross-functional experts from discovery to operations
- Translate expert knowledge into patient-centric development strategies
- Execute and communicate strategies to achieve CMC project goals
- Deliver drug product work packages for early-stage assets
- Create regulatory documents including QTPP and CMC sections
- Consolidate project results into high-level summary reports
- Participate in regulatory agency interactions and scientific advice
- Manage technical issues with local and global experts
- Oversee drug product projects outsourced to external partners
- Communicate project risks and strategies to management
- Plan personnel and budgetary resource requirements
- Distribute work packages within functional groups
- Contribute to global drug product development initiatives
Berufserfahrung
6 Jahre
Ausbildung
Bachelor-AbschlussODERMaster-Abschluss
Sprachen
Englisch – verhandlungssicherDeutsch – verhandlungssicher
Tools & Technologien
ICHEMAFDA
Benefits
Lockere Unternehmenskultur
- •Diverse work environment
- •Open corporate culture
Mentoring & Coaching
- •Intensive onboarding with mentor
Flexibles Arbeiten
- •Flexible work models
- •Healthy work-life balance
Gesundheits- & Fitnessangebote
- •Corporate health management
- •Comprehensive health programs
- •Exercise programs
Sonstige Vorteile
- •Company social benefits
Karriere- und Weiterentwicklung
- •International career opportunities
- •Strong international network
Weiterbildungsangebote
- •Top-tier development opportunities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens AbbVie 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?
- AbbVie
Associate Director/Director CMC Product Development(m/w/x)
Vollzeitnur vor OrtManagementLudwigshafen am Rhein - AbbVie
Project Manager Pharmaceutical Development Combination Products(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLudwigshafen am Rhein - AbbVie
Projekt Manager pharmazeutische Entwicklung, Kombinationsprodukte(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLudwigshafen am Rhein - AGC Biologics GmbH
Team Leader Process Development - Nucleic Acids (pDNA & mRNA)(m/w/x)
Vollzeitnur vor OrtSeniorHeidelberg
ABAbbVie
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
Ludwigshafen am Rhein
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
You will drive the pharmaceutical development of biological drug products by leading global strategy teams and coordinating cross-functional experts to deliver innovative, patient-centric solutions.
Anforderungen
- BS, Master's, PhD, or equivalent qualification
- Experience in formulation, manufacturing, or analytical development
- Bachelor's, Master's, or PhD in science
- Knowledge in Biologics drug product development
- Established expert in specific technical area
- Understanding of ICH, EMA, FDA regulations
- Experience with novel modality projects
- Excellent communication and stakeholder management skills
- Interpersonal skills and matrix environment leadership
- Structured, proactive, and reliable working style
- Comfort with ambiguity and risk-based decision-making
Aufgaben
- Lead biologics drug product development on global strategy teams
- Act as the primary contact for drug product topics
- Develop formulations, manufacturing processes, and container closure systems
- Collaborate with cross-functional experts from discovery to operations
- Translate expert knowledge into patient-centric development strategies
- Execute and communicate strategies to achieve CMC project goals
- Deliver drug product work packages for early-stage assets
- Create regulatory documents including QTPP and CMC sections
- Consolidate project results into high-level summary reports
- Participate in regulatory agency interactions and scientific advice
- Manage technical issues with local and global experts
- Oversee drug product projects outsourced to external partners
- Communicate project risks and strategies to management
- Plan personnel and budgetary resource requirements
- Distribute work packages within functional groups
- Contribute to global drug product development initiatives
Berufserfahrung
6 Jahre
Ausbildung
Bachelor-AbschlussODERMaster-Abschluss
Sprachen
Englisch – verhandlungssicherDeutsch – verhandlungssicher
Tools & Technologien
ICHEMAFDA
Benefits
Lockere Unternehmenskultur
- •Diverse work environment
- •Open corporate culture
Mentoring & Coaching
- •Intensive onboarding with mentor
Flexibles Arbeiten
- •Flexible work models
- •Healthy work-life balance
Gesundheits- & Fitnessangebote
- •Corporate health management
- •Comprehensive health programs
- •Exercise programs
Sonstige Vorteile
- •Company social benefits
Karriere- und Weiterentwicklung
- •International career opportunities
- •Strong international network
Weiterbildungsangebote
- •Top-tier development opportunities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens AbbVie 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
AbbVie
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen setzt sich für die Entdeckung und Bereitstellung innovativer Medikamente und Lösungen ein, die ernsthafte Gesundheitsprobleme lösen.
Noch nicht perfekt?
- AbbVie
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
Vollzeitnur vor OrtSeniorLudwigshafen am Rhein - AbbVie
Associate Director/Director CMC Product Development(m/w/x)
Vollzeitnur vor OrtManagementLudwigshafen am Rhein - AbbVie
Project Manager Pharmaceutical Development Combination Products(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLudwigshafen am Rhein - AbbVie
Projekt Manager pharmazeutische Entwicklung, Kombinationsprodukte(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLudwigshafen am Rhein - AGC Biologics GmbH
Team Leader Process Development - Nucleic Acids (pDNA & mRNA)(m/w/x)
Vollzeitnur vor OrtSeniorHeidelberg