Process Investigation Lead

Takeda; Cambridge (MA); On-site; USD 194,957 - 268,033; Full time

Job summary

Takeda in Cambridge, MA is seeking a leader to manage complex manufacturing investigations across commercial products. The role requires on-site leadership, cross-functional task forces, and data-driven problem solving using AI and digital tools.

You will drive digital transformation to modernize investigation processes, ensure GMP compliance, and collaborate with global sites and CMOs. Candidates should have 7–10 years in manufacturing and strong analytical skills, with travel as needed.

Qualifications

• Bachelor's degree in Life Science, Engineering, Manufacturing, or related field. An advanced degree (MS or PhD) is preferred.
• 7–10 years experience in manufacturing, troubleshooting methodology, best practices, and creating business processes.
• Lean Six Sigma Green/Black Belt certification or equivalent process improvement certification
• Experience in contract manufacturing is a plus
• Strong knowledge of GMP and regulatory compliance standards (FDA, EMA, ICH, etc.)
• Proficiency in root cause analysis tools (e.g., Fishbone Diagram, 5 Whys)
• Experience with statistical tools and software (e.g., Minitab, JMP) for data analysis
• Proven ability to lead cross-functional teams and manage multiple investigations
• Proven hands-on experience in Data Analytics is valuable
• Project management experience
• Proficiency in visualization tools (Miro, dashboards, PowerPoint)
• Excellent command of English (written and oral)
• Experience with AI technologies to drive business excellence and transformation

Responsibilities

• Lead and resolve complex manufacturing investigations across all commercial products.
• Stand up and manage cross-functional task forces (internal sites and CMOs).
• Develop and implement problem-solving methodologies for data-driven decisions.
• Champion integration of AI and digital tools into troubleshooting.
• Lead digital transformation initiatives to modernize investigation processes.
• Apply advanced data analytics to solve manufacturing problems and enhance decisions.
• Drive consistency in problem-solving practices across the network.
• Travel on-site for critical events and on-site support as needed.

Skills

Root cause analysis

Data analytics

Project management

Lean Six Sigma

AI in manufacturing

GMP compliance

Education

Bachelor's in Life Science/Engineering

MS/PhD preferred

Tools

Minitab

JMP

Dashboards/Visualization

Job description

Locations

CHE - Glattpark (Opfikon) - Zurich HQCambridge, MA

Job Description

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.

How you will contribute

• Demonstrate a strong commitment to on-site support, including frequent, short-notice global travel and the ability to spend extended periods away from home during critical events.
• Lead end-to-end troubleshooting of complex, high-impact manufacturing issues to ensure timely and effective resolution.
• 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 to drive structured, data-driven decision making.
• Partner with cross-functional stakeholders to identify, prioritize, and implement process improvements and innovation opportunities.
• Apply advanced data analytics and AI tools to solve complex manufacturing problems and enhance operational decision making.
• Leverage automation and digital solutions to improve efficiency, scalability, and overall productivity.
• Drive consistency in problem-solving practices across the network, reinforcing a high-performing, solution-oriented culture.

What you bring to Takeda

• Bachelor's degree in Life Science, Engineering, Manufacturing, or related field. An advanced degree (MS or PhD) is preferred.
• Minimum 7-10 years experience in manufacturing, troubleshooting methodology, best practices, and creating business processes.
• Lean Six Sigma Green/Black Belt certification or equivalent process improvement certification
• Experience in contract manufacturing business is a plus
• Strong knowledge of GMP and regulatory compliance standards (FDA, EMA, ICH, etc.).
• Proficiency in root cause analysis tools (e.g., Fishbone Diagram, 5 Whys, etc.).
• Experience with statistical tools and software (e.g., Minitab, JMP) for data analysis.
• Proven ability to lead cross-functional teams and manage multiple investigations simultaneously.
• Proven hands‑on experience in Data Analytics is a valuable asset.
• Project management experience.
• Proficiency in visualization (Miro, white boards, dashboards, PowerPoint, etc.)
• Excellent command of English (both written and oral).
• Experience with AI technologies to drive business excellence and transformation

Base Salary Range

CHF159,300.00 - CHF219,010.00

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time