AbbVie
Analytical Lead – Protein Analytics in Early Analytical Development R&D(m/w/x)
Vollzeit/Teilzeitnur vor OrtSenior
Ludwigshafen am Rhein
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
ABAbbVie
Analytical Lead – Protein Analytics in Early Analytical Development R&D(m/w/x)
Ludwigshafen am Rhein
Vollzeit, TeilzeitVor OrtSenior
Nejo KI-Zusammenfassung
Developing analytical control strategies for biological assets in drug development. Extensive experience in a scientific discipline required. Flexible work models, intensive onboarding with mentor.
Anforderungen
- BS or equivalent education and extensive experience
- MS or equivalent education with typically 12+ years of experience
- PhD with typically 6+ years of experience in area or scientific area of discipline
- Bachelor’s Degree in Science related field with 16 years of related work
- Master’s Degree Science or PharmD with 14 years of related work
- PhD in Science or related field with 8 years of related work experience
- Comprehensive knowledge of protein analytics and bioassays
- Knowledge of protein extended characterization
- Experience in regulated quality control environment
- Experience in analytical development of proteins and antibodies
- Experience in analytical development of protein derivatives
- Thorough understanding of ICH regulatory requirements
- Thorough understanding of EMA regulatory requirements
- Thorough understanding of FDA regulatory requirements
- Experience in communication with external partners
- Experience in work with external partners
- Experience with cooperations
- Experience with external laboratories
- Experience in early stage biologic development
- IND exposure
- Excellent communication skills
- Fluent English
Aufgaben
- Represent Early Bio CMC Analytical Function in global Product Development Strategy Teams
- Develop and implement analytical control strategies for biological assets
- Collaborate with Formulation Lead, Device Lead, and other development functions
- Conceive and execute analytical development strategies to meet CMC project goals
- Design and deliver analytical work packages, including stability and comparability studies
- Cover a range of analytical test methods for quality control and characterization
- Prepare and participate in regulatory agency interactions and meetings
- Manage analytical programs with external partners
- Create and author project-level analytical documents and plans
- Consolidate and summarize analytical test results
- Engage with analytical experts on scientific and project-related issues
- Collaborate with cross-functional SMEs to solve technical issues
- Communicate project strategy, key issues, and risks to the team and management
- Present complex technical topics to the development team and management
Berufserfahrung
- 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
Benefits
Lockere Unternehmenskultur
- Diverse work environment
- Open corporate culture
- International network
- Great Place to Work recognition
Mentoring & Coaching
- Intensive onboarding with mentor
Flexibles Arbeiten
- Flexible work models
- Healthy work-life balance
Gesundheits- & Fitnessangebote
- Corporate health management
Sonstige Vorteile
- Company social benefits
- Equality, equity, diversity and inclusion
Karriere- und Weiterentwicklung
- Career opportunities
Weiterbildungsangebote
- Development opportunities
Fokus auf Nachhaltigkeit
- Environmental and community focus
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?
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Bench Scientist II / Senior Bench Scientist I – Mass Spectrometry & Characterization of Therapeutic Proteins(m/w/x)
Vollzeitnur vor OrtSeniorLudwigshafen am Rhein - AbbVie
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
Vollzeitnur vor OrtSeniorLudwigshafen am Rhein - AbbVie
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
Vollzeitnur vor OrtSeniorLudwigshafen am Rhein
ABAbbVie
Analytical Lead – Protein Analytics in Early Analytical Development R&D(m/w/x)
Ludwigshafen am Rhein
Vollzeit, TeilzeitVor OrtSenior
Nejo KI-Zusammenfassung
Developing analytical control strategies for biological assets in drug development. Extensive experience in a scientific discipline required. Flexible work models, intensive onboarding with mentor.
Anforderungen
- BS or equivalent education and extensive experience
- MS or equivalent education with typically 12+ years of experience
- PhD with typically 6+ years of experience in area or scientific area of discipline
- Bachelor’s Degree in Science related field with 16 years of related work
- Master’s Degree Science or PharmD with 14 years of related work
- PhD in Science or related field with 8 years of related work experience
- Comprehensive knowledge of protein analytics and bioassays
- Knowledge of protein extended characterization
- Experience in regulated quality control environment
- Experience in analytical development of proteins and antibodies
- Experience in analytical development of protein derivatives
- Thorough understanding of ICH regulatory requirements
- Thorough understanding of EMA regulatory requirements
- Thorough understanding of FDA regulatory requirements
- Experience in communication with external partners
- Experience in work with external partners
- Experience with cooperations
- Experience with external laboratories
- Experience in early stage biologic development
- IND exposure
- Excellent communication skills
- Fluent English
Aufgaben
- Represent Early Bio CMC Analytical Function in global Product Development Strategy Teams
- Develop and implement analytical control strategies for biological assets
- Collaborate with Formulation Lead, Device Lead, and other development functions
- Conceive and execute analytical development strategies to meet CMC project goals
- Design and deliver analytical work packages, including stability and comparability studies
- Cover a range of analytical test methods for quality control and characterization
- Prepare and participate in regulatory agency interactions and meetings
- Manage analytical programs with external partners
- Create and author project-level analytical documents and plans
- Consolidate and summarize analytical test results
- Engage with analytical experts on scientific and project-related issues
- Collaborate with cross-functional SMEs to solve technical issues
- Communicate project strategy, key issues, and risks to the team and management
- Present complex technical topics to the development team and management
Berufserfahrung
- 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
Benefits
Lockere Unternehmenskultur
- Diverse work environment
- Open corporate culture
- International network
- Great Place to Work recognition
Mentoring & Coaching
- Intensive onboarding with mentor
Flexibles Arbeiten
- Flexible work models
- Healthy work-life balance
Gesundheits- & Fitnessangebote
- Corporate health management
Sonstige Vorteile
- Company social benefits
- Equality, equity, diversity and inclusion
Karriere- und Weiterentwicklung
- Career opportunities
Weiterbildungsangebote
- Development opportunities
Fokus auf Nachhaltigkeit
- Environmental and community focus
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
Analytical Lead – Protein Analytics in Early Analytical Development R&D(m/w/x)
Vollzeit/Teilzeitnur 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 - AbbVie
Bench Scientist II / Senior Bench Scientist I – Mass Spectrometry & Characterization of Therapeutic Proteins(m/w/x)
Vollzeitnur vor OrtSeniorLudwigshafen am Rhein - AbbVie
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
Vollzeitnur vor OrtSeniorLudwigshafen am Rhein - AbbVie
Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)
Vollzeitnur vor OrtSeniorLudwigshafen am Rhein