AbbVie
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
Vollzeitnur vor OrtSenior
Ludwigshafen am Rhein
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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
Biologics drug product formulation and manufacturing process development, designing container closure systems for early-stage assets at a biotech firm. Established expertise in biologics drug product development and regulatory requirements needed. Intensive onboarding with mentor, flexible work models.
Anforderungen
- BS, Master's, or PhD in relevant life science
- Bachelor's, Master's, or PhD in science related field
- Knowledge in Biologics drug product development
- Established expert in specific development areas
- Understanding of major regulatory requirements
- 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 global drug product development strategy teams
- Act as the primary contact for CMC directors
- Develop formulations and manufacturing processes for biological assets
- Design container closure systems for early-stage products
- Collaborate with analytical, device, and regulatory experts
- Connect discovery teams with toxicology and drug substance functions
- Translate expert knowledge into patient-centric development strategies
- Execute and communicate strategies to achieve CMC goals
- Deliver drug product work packages for clinical phases
- Draft regulatory submission documents including CTAs and INDs
- Prepare briefing books for regulatory agency interactions
- Manage technical issues with local and global experts
- Oversee outsourced development projects with external partners
- Communicate project risks and strategies to management
- Plan personnel and budgetary resource requirements
- Distribute work packages within functional development groups
- Participate in global drug product development initiatives
Berufserfahrung
- 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- ICH
- EMA
- FDA
- CCS development
Benefits
Attraktive Vergütung
- Attractive salary
Lockere Unternehmenskultur
- Diverse work environment
- Open corporate culture
Mentoring & Coaching
- Intensive onboarding with mentor
Flexibles Arbeiten
- Flexible work models
Gesundheits- & Fitnessangebote
- Comprehensive health and exercise programs
Sonstige Vorteile
- Company social benefits
Karriere- und Weiterentwicklung
- International career opportunities
- Attractive development opportunities
- Strong international network
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
Scientist I/II(m/w/x)
VollzeitBefristeter Vertragnur vor OrtSeniorLudwigshafen am Rhein - AbbVie
Scientist I – Bioassay Sciences and Development(m/w/x)
Vollzeit/Teilzeitnur vor OrtBerufserfahrenLudwigshafen am Rhein - AbbVie
Bench Scientist II / Senior Bench Scientist I – Mass Spectrometry & Characterization of Therapeutic Proteins(m/w/x)
Vollzeitnur vor OrtSeniorLudwigshafen am Rhein - AbbVie
Bench Scientist II / Senior Bench Scientist I – Mass Spectrometry & Characterization of Therapeutic Proteins(m/w/x)
Vollzeitnur vor OrtSeniorLudwigshafen am Rhein
ABAbbVie
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
Ludwigshafen am Rhein
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Biologics drug product formulation and manufacturing process development, designing container closure systems for early-stage assets at a biotech firm. Established expertise in biologics drug product development and regulatory requirements needed. Intensive onboarding with mentor, flexible work models.
Anforderungen
- BS, Master's, or PhD in relevant life science
- Bachelor's, Master's, or PhD in science related field
- Knowledge in Biologics drug product development
- Established expert in specific development areas
- Understanding of major regulatory requirements
- 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 global drug product development strategy teams
- Act as the primary contact for CMC directors
- Develop formulations and manufacturing processes for biological assets
- Design container closure systems for early-stage products
- Collaborate with analytical, device, and regulatory experts
- Connect discovery teams with toxicology and drug substance functions
- Translate expert knowledge into patient-centric development strategies
- Execute and communicate strategies to achieve CMC goals
- Deliver drug product work packages for clinical phases
- Draft regulatory submission documents including CTAs and INDs
- Prepare briefing books for regulatory agency interactions
- Manage technical issues with local and global experts
- Oversee outsourced development projects with external partners
- Communicate project risks and strategies to management
- Plan personnel and budgetary resource requirements
- Distribute work packages within functional development groups
- Participate in global drug product development initiatives
Berufserfahrung
- 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- ICH
- EMA
- FDA
- CCS development
Benefits
Attraktive Vergütung
- Attractive salary
Lockere Unternehmenskultur
- Diverse work environment
- Open corporate culture
Mentoring & Coaching
- Intensive onboarding with mentor
Flexibles Arbeiten
- Flexible work models
Gesundheits- & Fitnessangebote
- Comprehensive health and exercise programs
Sonstige Vorteile
- Company social benefits
Karriere- und Weiterentwicklung
- International career opportunities
- Attractive development opportunities
- Strong international network
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
Scientist I/II(m/w/x)
VollzeitBefristeter Vertragnur vor OrtSeniorLudwigshafen am Rhein - AbbVie
Scientist I – Bioassay Sciences and Development(m/w/x)
Vollzeit/Teilzeitnur vor OrtBerufserfahrenLudwigshafen am Rhein - AbbVie
Bench Scientist II / Senior Bench Scientist I – Mass Spectrometry & Characterization of Therapeutic Proteins(m/w/x)
Vollzeitnur vor OrtSeniorLudwigshafen am Rhein - AbbVie
Bench Scientist II / Senior Bench Scientist I – Mass Spectrometry & Characterization of Therapeutic Proteins(m/w/x)
Vollzeitnur vor OrtSeniorLudwigshafen am Rhein