Scientist, Analytical Science & Method Transfer (m/f/d)

Your Profile:

Core Expertise

• Analytical method transfer strategies (internal labs and CMOs)
  
• Analytical method development, validation, and lifecycle management
  
• Advanced analytical techniques:
  • HPLC / UPLC
    
  • GC
    
  • Dissolution
    
  • Spectroscopy
• Troubleshooting & deviation management (OOS/OOT investigations)
  
• Data evaluation
  
• • GMP, ICH guidelines, and regulatory compliance
  Professional Skills
  
• Experience working with contract manufacturers (CMOs/CDMOs) in a global environment
  
• Strong scientific problem-solving and troubleshooting mindset
  
• Excellent communication skills for interfacing with internal teams and external partners
  
• Structured and results-driven project management capabilities
  
• High level of accountability, persistence, and attention to detail
  
• Ability to manage multiple priorities in a regulated environment

Qualifications

• Degree in Chemistry, Pharmaceutical Sciences, or related field (e.g., HTL, ETH, MSc or equivalent)
  
• Minimum 5 years of experience in analytical development or quality control within the pharmaceutical industry
  
• Proven track record in method transfer and analytical troubleshooting
  
• Solid knowledge of GMP, ICH, and ISO standards

Your Tasks:

• Lead and coordinate analytical method transfer activities to or between Quality Control laboratories and external contract manufacturers
  
• Act as SME (Subject Matter Expert) for analytical issues during technology transfer and commercial manufacturing of drug substances and drug products
  
• Perform scientific troubleshooting for analytical methods (e.g., HPLC, GC, spectroscopy) in response to OOS, OOT, and atypical results
  
• Support CMOs/CDMOs in establishing analytical methods, resolving analytical challenges, ensuring alignment with internal standards and regulatory dossiers
  
• In case of method transfer by revalidation: design, optimize, and validate analytical methods according to ICH guidelines and GMP requirements
  
• Review and approve method transfer protocols, validation reports, and analytical documentation
  
• Drive root cause analysis and define CAPAs for analytical deviations in collaboration with cross-functional teams
  
• Ensure consistent method lifecycle management, including continuous improvement and robustness enhancement
  
• Support regulatory submissions by preparing and reviewing analytical sections (e.g., CTD Module 3) for new laboratories and CMOs
  
• Act as a key interface for Analytical Science & Method Transfer between Technology transfer team, Quality Assurance, Regulatory Affairs, and external partners

» Job description