Associate Director-Process Engineer SM API Process Sci

Role Summary

Associate Director-Process Engineer SM API Process Sci responsible for providing process engineering support in batch or continuous API platforms, applying chemical engineering and process chemistry fundamentals from clinical to commercial stages. Integrates mechanistic modelling, process simulation, and analysis into current and future processes to enhance process understanding and controls. Identifies and implements continuous improvement opportunities and supports global marketing applications and regulatory responses.

Responsibilities

• Leads the GMSci, Global Process Science, Small Molecules API Manufacturing Science organization; may serve as Takeda‚Äôs expert on small molecule API processes and technologies.
• Provides leadership for API Manufacturing Process Characterization, Technology Transfer, Process validation, Risk assessment, Global expansion, COGs management, Regulatory Activities, and Process/Product knowledge.
• Leads projects within Takeda product portfolio to support Small Molecules API Manufacturing Sciences activities.
• Develops and implements strategies for continuous improvement in late-stage manufacturing of Marketed Products.
• Leads the manufacturing strategy for key Takeda products at internal networks and external CMOs.
• Creates systems and procedures for best practices in commercial technology transfer and process validation.
• Leads the central hub of manufacturing process knowledge and ensures knowledge sharing across global products and sites.
• Collaborates with other functions within GMS and with Manufacturing Operating Unit Site leads, Local Technical Services, Pharmaceutical Sciences, and Global Quality/Regulatory CMC.

Leadership

• Provides vision and strategy for manufacturing technology projects.
• Leads and influences the local MSci organization for global manufacturing strategy alignment.
• Communicates Global Manufacturing Sciences visions across functions.
• Understands API manufacturing from development to commercial scale.
• Has strong knowledge of Organic/Pharmaceutical chemistry.
• Works in cross-functional teams (Engineering, Manufacturing Operations, Manufacturing Sciences, CMC).
• Uses root cause analysis to investigate issues and implement corrective/preventive actions.
• Provides SME support for Due Diligence of M&A and other in-licensing activities.
• Leads/supports tech transfer of new processes and unit operations across batch and continuous platforms.

What you bring to Takeda

• MS/PhD in Chemical or Process Engineering or Pharmaceutical Engineering.
• At least 5+ years in a cGMP environment.
• At least 5+ years of pharmaceutical industry experience in small molecules (preferred).
• Self-motivated with strong interpersonal skills and ability to solve complex problems creatively.
• Strategic thinking and a patient-centered mindset.
• Collaborative environment-building skills and focus on key priorities to deliver results.
• Ability to elevate capabilities for current and future needs.