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RORoche

Group Head in Analytical Development & Quality Control(m/w/x)

Basel
Full-timeOn-siteManagement

Leading analytical projects for biotechnological development products at a biopharmaceutical firm, managing a team of six associates. PhD in Analytics or similar, with 3-5 years biopharmaceutical industry experience and protein analytics focus required. Direct impact on investigational medicinal products via IND/BLA regulatory filings.

Requirements

  • PhD in Analytics, Biochemistry, Pharmacy, or similar
  • 3-5 years biopharmaceutical industry experience
  • Focus on protein analytics and characterization
  • Experience in a GMP environment preferred
  • Experience with combination products is advantageous
  • Experience developing biophysical/biochemical protein analysis methods
  • Excellent leadership skills
  • Track record in cross functional collaboration
  • Ability to influence stakeholders at all levels
  • Self-motivation and pro-active work style
  • Responsibility and result-orientation
  • Excellent teamwork and relationship building skills
  • Statistics expertise and statistical model application
  • High affinity to digitalization preferred
  • Experienced scientist status

Tasks

  • Lead analytical projects within global technical development teams
  • Coordinate all analytical activities for biotechnological development products
  • Manage and prioritize workload for a team of six associates
  • Set specifications and shelf life for investigational medicinal products
  • Support IND and BLA regulatory filings
  • Evaluate and implement new analytical technologies and test methods
  • Manage analytical method validation and transfer processes
  • Oversee quality control for preclinical and clinical study batches
  • Ensure GxP-compliant analytics according to current guidelines and SOPs

Work Experience

  • 3 - 5 years

Education

  • Doctoral / PhD

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • Protein analytics
  • Biophysical analysis
  • Biochemical analysis
  • Statistical models
  • GMP
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche 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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