Process Investigation Lead

About the role:

• Lead and resolve complex manufacturing investigations across all commercial products.
• Lead and manage task forces to address critical situations effectively.
• Develop and implement problem-solving methodologies.
• Champion the integration of AI and digital tools into manufacturing troubleshooting and decision-making.
• Lead digital transformation initiatives to modernize investigation processes and operational excellence frameworks.

• Provide frequent, short-notice on-site support, including travel and extended time away during critical events.
• Lead end-to-end troubleshooting of complex, high-impact manufacturing issues.
• Stand up and manage cross-functional task forces (internal sites and CMOs) to address urgent, business-critical challenges.
• Design, standardize, and continuously improve problem-solving methodologies for structured, data-driven decisions.
• Partner with stakeholders to identify, prioritize, and implement process improvements and innovation opportunities.
• Apply advanced data analytics and AI tools to solve complex manufacturing problems.
• Leverage automation and digital solutions to improve efficiency, scalability, and productivity.
• Drive consistency in problem-solving practices across the network.

• Bachelor’s degree in Life Science, Engineering, Manufacturing, or related field; MS/PhD preferred.
• 7–10 years manufacturing/troubleshooting methodology and process development experience.
• Lean Six Sigma Green/Black Belt (or equivalent).
• GMP and regulatory compliance knowledge (FDA, EMA, ICH, etc.).
• Root cause analysis tools (e.g., Fishbone Diagram, 5 Whys).
• Statistical tools (e.g., Minitab, JMP).
• Ability to lead cross-functional teams and manage multiple investigations.
• Data analytics experience (valuable).
• Project management experience.
• Visualization proficiency (e.g., Miro, dashboards, PowerPoint).
• English proficiency (written and oral).
• Experience with AI technologies for transformation.