Global MSAT Senior Product & Process Steward(m/w/x)

Requirements

• Seasoned CMC leadership experience
• Scientific rigor and strategic vision
• Ability to influence global matrix organizations
• Accountability and high-impact decision-making
• Advanced degree in Chemistry or related discipline (PhD preferred)
• 7+ years industry experience in drug substance development or commercial manufacturing
• Expertise in process development and validation
• Expertise in technology transfer and synthetic molecule manufacturing
• Proactive, structured mindset and quality focus
• Ability to inspire trust and align stakeholders

Tasks

• Own the drug substance lifecycle from development to divestment
• Ensure robust, efficient, and compliant manufacturing processes
• Drive technical industrialization strategies and CDMO site selections
• Lead technology transfers to the CDMO network
• Support manufacturing operations and equipment alignment at CDMO sites
• Optimize processes and troubleshoot technical issues
• Provide technical oversight during start-up and routine operations
• Oversee validation activities and strategies at CDMOs
• Ensure validation meets all regulatory expectations
• Author and review technical reports and validation documents
• Prepare regulatory submissions for industrialization and lifecycle management
• Anticipate and mitigate risks to safeguard supply chains
• Secure delivery of starting materials and drug substances
• Elevate manufacturing performance through data-driven decisions
• Enhance process efficiency, safety, sustainability, and compliance

Education

Languages

Tools & Technologies