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ABAbbVie

Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)

Ludwigshafen am Rhein
Full-timeOn-siteSenior

Leading global strategy teams for biologics formulation, manufacturing processes, and container closure systems. Established expertise in a specific technical area and a science PhD or equivalent required. Intensive onboarding with mentor, flexible work models.

Requirements

  • BS, Master's, PhD, or equivalent qualification
  • Experience in formulation, manufacturing, or analytical development
  • Bachelor's, Master's, or PhD in science
  • Knowledge in Biologics drug product development
  • Established expert in specific technical area
  • Understanding of ICH, EMA, FDA regulations
  • 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

Tasks

  • Lead biologics drug product development on global strategy teams
  • Act as the primary contact for drug product topics
  • Develop formulations, manufacturing processes, and container closure systems
  • Collaborate with cross-functional experts from discovery to operations
  • Translate expert knowledge into patient-centric development strategies
  • Execute and communicate strategies to achieve CMC project goals
  • Deliver drug product work packages for early-stage assets
  • Create regulatory documents including QTPP and CMC sections
  • Consolidate project results into high-level summary reports
  • Participate in regulatory agency interactions and scientific advice
  • Manage technical issues with local and global experts
  • Oversee drug product projects outsourced to external partners
  • Communicate project risks and strategies to management
  • Plan personnel and budgetary resource requirements
  • Distribute work packages within functional groups
  • Contribute to global drug product development initiatives

Work Experience

  • 6 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishBusiness Fluent
  • GermanBusiness Fluent

Tools & Technologies

  • ICH
  • EMA
  • FDA

Benefits

Informal Culture

  • Diverse work environment
  • Open corporate culture

Mentorship & Coaching

  • Intensive onboarding with mentor

Flexible Working

  • Flexible work models
  • Healthy work-life balance

Healthcare & Fitness

  • Corporate health management
  • Comprehensive health programs
  • Exercise programs

Other Benefits

  • Company social benefits

Career Advancement

  • International career opportunities
  • Strong international network

Learning & Development

  • Top-tier development opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of AbbVie and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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