AbbVie
Principal Research Scientist I/II Biologics Quality Control in Biologics Analytical R&D (m/w/x)
Vollzeitmit HomeofficeSenior
Ludwigshafen am Rhein
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ABAbbVie
Principal Research Scientist I/II Biologics Quality Control in Biologics Analytical R&D (m/w/x)
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Leading scientists in separation-based assays for biologics characterization and validation. Expertise in HPLC and capillary electrophoresis required. Flexible work models, intensive onboarding with mentor.
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Anforderungen
- PhD in chemistry, biology, biochemistry, chemical engineering, or related technical discipline
- Proven experience managing and leading analytical development and QC activities for biologic development
- Experience in role of Head of Quality Control (HQC) according to § 12 AMWHV is a plus
- Expertise in protein and impurity analysis techniques (HPLC, capillary electrophoresis)
- Experience with mass spectrometry and ELISA is a plus
- Skilled in technical writing and authoring/reviewing regulatory documents
- Strong people leadership skills and ability to foster team environment
- Excellent communication and interpersonal skills
- Ability to work effectively across functions
- Ability to comprehend and adapt to new situations with open mindset
- Critical thinking and troubleshooting skills
- Ability to lead and manage multiple complex projects
- Independent, self-motivated, proactive individual
Aufgaben
- Lead and mentor scientists in separation-based assays
- Support biologics mab and DS process development
- Support biologics characterization and validation
- Support GMP manufacturing investigation activities
- Serve as analytical representative in CMC teams
- Support early-stage biologics pipeline assets
- Balance stakeholder expectations for effective collaboration
- Serve as subject matter expert for analytical test methods
- Provide expertise for method development, execution, and troubleshooting
- Evaluate and select effective analytical technologies and methods
- Support automation of high-throughput analytical methods
- Drive timely delivery of high-quality testing results
- Participate in preparation and review of technical documents
- Take responsibility for analytical test method development
- Take responsibility for analytical test method validation
- Manage test method transfer to internal and external partners
- Perform batch release activities
- Collaborate with other analytical teams on program transition
- Collaborate on workflow and program strategic alignment
- Provide guidance on project management and analytical strategy
- Provide guidance on technical skills related to separation techniques
- Communicate project data, issues, and risks to relevant teams
- Promote proactive risk resolution across functional areas
- Demonstrate scientific excellence and advance science
- Implement novel analytical techniques to enhance method robustness
- Implement novel analytical techniques to expand analytical capabilities
Berufserfahrung
8 Jahre
Ausbildung
Doktor / Ph.D.
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
HPLCcapillary electrophoresismass spectrometryELISA
Benefits
Mentoring & Coaching
- Intensive onboarding with mentor
Flexibles Arbeiten
- Flexible work models
Gesundheits- & Fitnessangebote
- Corporate health management
Sonstige Vorteile
- Company social benefits
Karriere- und Weiterentwicklung
- Career opportunities
Weiterbildungsangebote
- Development opportunities
Lockere Unternehmenskultur
- International network
- Great Place to Work recognition
Fokus auf Nachhaltigkeit
- Environmental and community focus
Gemeinnützige Ausrichtung
- Equality, equity, diversity, and inclusion commitment
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AB
PharmaceuticalsLudwigshafen am Rhein
Das Unternehmen setzt sich für die Entdeckung und Bereitstellung innovativer Medikamente und Lösungen ein, die ernsthafte Gesundheitsprobleme lösen.
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