CMC Biologics Analytical Principal Scientist (m/f/d)

Your Profile:

• 15+ years of experience in the pharmaceutical industry focusing in analytical development.
  
• Experience in managing external and internal activities.
  
• Experience in data analysis and statistics.
  
• Experience with NBEs is preferred.
  
• Knowledge of GMP, GLP, GCP, Regulatory processes, a plus.
  
• Strong collaboration skills and experience working with external partners
  
• Communication skills in English written and oral

Your Tasks:

• Lead the analytical strategy for early/late programs.
  
• Day-to-day oversight of analytical activities performed at partnered CDMOs and CROs according to latest industry standards and regulatory guidance.
  
• Contribution to set up and development of in-house/outsourced analytical activities
  
• Definition of DS & DP specification according to applicable regulatory guidelines
  
• Prepare the plan for stability studies, reference standard, comparability studies
  
• Prepare and/or review technical documents including method development, method validation, transfer protocols and reports.
  
• Authoring and review of CMC regulatory analytical submissions documents
  
• Work closely with Drug Substance, Drug Product and Characterization Subject Matter Experts to develop analytical, characterization and comparability strategies
  
• Support defining/refining required processes for analytical/characterization activities
  
• Experience with analytical methods for GMP manufacturing
  
• Understanding of the detailed requirements for analytical validation and up to date with current trends
  
• Might include CMC leadership activities.

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