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ABAbbVie

Analytical Lead – Protein Analytics in Early Analytical Development R&D(m/w/x)

Ludwigshafen am Rhein
Vollzeit, TeilzeitVor OrtSenior

Developing analytical control strategies for biological assets in early R&D. Extensive experience in science-related fields required. Flexible work models, corporate health management.

Anforderungen

  • BS or equivalent education and extensive experience
  • MS or equivalent education with extensive experience
  • PhD with extensive experience
  • Bachelor’s Degree in Science related field with extensive work
  • Master’s Degree Science or PharmD with extensive work
  • PhD in Science or related field with extensive work experience
  • Comprehensive knowledge of protein analytics and bioassays
  • Versed in protein extended characterization
  • Experience in regulated quality control environment
  • Experience in analytical development of proteins and antibodies/derivatives
  • Thorough understanding of ICH, EMA, FDA regulatory requirements
  • Experience in communication with external partners
  • Experience working 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, execute, and communicate analytical development strategies
  • Design and deliver analytical work packages on time
  • Conduct stability and comparability studies
  • Manage analytical test methods for quality control and characterization
  • Prepare and participate in regulatory agency interactions
  • Respond to agency requests and attend agency meetings
  • Oversee programs with external partners
  • Create and author project-level analytical documents
  • Consolidate analytical test results into summary reports
  • Engage analytical experts in scientific and project-related discussions
  • Collaborate with cross-functional SMEs to solve technical issues
  • Communicate project strategy, key issues, and risks
  • Present complex technical topics to the development team and management

Berufserfahrung

  • 6 Jahre

Ausbildung

  • Bachelor-AbschlussODER
  • Master-Abschluss

Sprachen

  • Englischfließend

Benefits

Flexibles Arbeiten

  • Flexible work models
  • Healthy work-life balance

Gesundheits- & Fitnessangebote

  • Corporate health management
  • Health programs
  • Exercise programs

Sonstige Vorteile

  • Company social benefits
  • International organization

Karriere- und Weiterentwicklung

  • Career opportunities

Weiterbildungsangebote

  • Development opportunities

Lockere Unternehmenskultur

  • International network
  • Great Place to Work recognition
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.

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