Associate Director, API Process Engineering

Role Summary

Associate Director, API Process Engineering — Takeda’s global expert for small-molecule API manufacturing processes across batch and continuous platforms, applying chemical engineering and process chemistry fundamentals to design, scale, and control API processes from clinical development through commercial supply.

Responsibilities

• Lead the Small Molecules API Manufacturing Sciences activities within Global Process Science, serving as expert for small-molecule API processes and technologies.
• Provide process engineering support for batch and continuous API platforms from clinical through commercial stages, integrating process chemistry and engineering perspectives.
• Apply mechanistic modelling, process simulation, and quantitative analysis to enhance process understanding and enable robust process control.
• Lead API manufacturing process characterization, including risk assessments and definition of critical process parameters and controls.
• Lead technology transfer of API processes between internal sites and external CMOs, ensuring robust, reproducible, and compliant implementation.
• Lead API process validation activities, including strategy, protocol design, execution support, and data evaluation.
• Develop and implement strategies for continuous improvement of marketed API processes, including yield optimization, robustness improvements, cost of goods (COGs) reduction, and capacity expansion.
• Establish and maintain systems and procedures for best practice in commercial technology transfer and process validation.
• Build and oversee a central knowledge base of API process and product understanding, ensuring lessons learned are shared across products, sites, and functions.
• Collaborate closely with GMS functions, site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC.
• Provide technical support to marketing applications for global markets and lead preparation of responses to regulatory questions from health authorities.
• Utilize structured root cause analysis techniques to investigate process and equipment issues and deliver robust, sustainable corrective and preventive actions.
• Provide subject matter expertise for due diligence in mergers and acquisitions and in-licensing evaluations.

Qualifications

• At least a Master‚Äôs degree in Chemical Engineering, Process Engineering, or Pharmaceutical Engineering.
• At least 5 years of experience in a cGMP manufacturing environment and at least 5 years of pharmaceutical industry experience in small-molecule APIs.
• Strong foundation in organic/pharmaceutical chemistry and chemical engineering, with applied experience in API manufacturing processes.
• In-depth understanding of pharmaceutical manufacturing processes, ICH guidelines, and global regulatory requirements relevant to API processes.
• Demonstrated experience in mechanistic modelling, process simulation, and data-driven process optimization.
• Proven track record leading API process characterization, technology transfer, process validation, and lifecycle changes in a multi-site or global context.
• Strong problem-solving, project management, and stakeholder management skills; ability to resolve conflicts and drive decisions in cross-functional teams.
• Excellent written and verbal communication skills, with experience preparing technical reports and presenting project results.
• Ability to work independently and proactively while collaborating within multi-disciplinary teams.
• Commitment to sharing knowledge across functions and sites and building sustainable technical capabilities.
• Intellectual curiosity about technology and new ways of working, with a collaborative and open mindset.
• Willingness to travel to international manufacturing sites and collaborate with site teams on complex issues.

Education

• Master‚Äôs degree in related field as specified above.