Global MSAT Senior Analytical Steward(m/w/x)

Requirements

• Advanced degree in scientific discipline or related
• 7+ years relevant industry experience
• Knowledge of Analytical Procedure Lifecycle
• Understanding of ICH Q8 and M4
• Strong collaboration and communication skills
• Proactive, structured mindset
• Focus on quality, compliance, and reliability
• Flexibility for international collaboration hours

Tasks

• Oversee and drive Analytical Science and Technology activities
• Transfer analytical methods to the CDMO network
• Enable industrialization and reliable commercial manufacturing
• Ensure industrialization readiness and regulatory compliance
• Align analytical control strategies with manufacturing strategy
• Manage analytical method transfers for product launches
• Ensure effective knowledge transfer with partner sites
• Support analytical operations at CDMO QC laboratories
• Optimize and troubleshoot analytical methods
• Provide technical oversight during start-up and operations
• Oversee validation activities and define testing parameters
• Assess method performance and validation strategies
• Author and review technical and validation documents
• Prepare regulatory submissions for lifecycle management
• Ensure alignment with ICH M4 and submission requirements
• Contribute to cross-functional technical oversight teams
• Serve as subject matter expert in procedure lifecycle management

Work Experience

Education

Languages

Tools & Technologies