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ABAbbVie

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

Ludwigshafen am Rhein
Full-time, Part-timeOn-siteSenior

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

Requirements

  • 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

Tasks

  • 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

Work Experience

  • 6 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishFluent

Benefits

Flexible Working

  • Flexible work models
  • Healthy work-life balance

Healthcare & Fitness

  • Corporate health management
  • Health programs
  • Exercise programs

Other Benefits

  • Company social benefits
  • International organization

Career Advancement

  • Career opportunities

Learning & Development

  • Development opportunities

Informal Culture

  • International network
  • Great Place to Work recognition
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