Associate Director, API Process Engineering

Takeda

About The Position

As Associate Director, API Process Engineering, you will be Takeda’s global expert for small-molecule API manufacturing processes across batch and continuous platforms. You will apply chemical engineering and process chemistry fundamentals to design, scale, and control API processes from clinical development through commercial supply. Through the integration of mechanistic modelling, process simulation, and rigorous data analysis you will deepen process understanding, strengthen control strategies, and support regulatory submissions for global markets. You will become the central hub for API process knowledge, driving best practices and continuous improvement across Takeda’s manufacturing network and external CMOs.

Requirements

At least a Master's degree in an area related to 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 (these may overlap).
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 current 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, including the ability to resolve conflicts and drive clear decisions in cross-functional teams.
Excellent written and verbal communication skills, including experience preparing high-quality technical reports and presenting project results to diverse audiences.
Ability to work independently and proactively while collaborating effectively within multi-disciplinary teams (Engineering, Manufacturing Operations, Manufacturing Sciences, CMC teams, and others).
Commitment to sharing knowledge across functions and sites and to building sustainable technical capabilities in the organization.
Intellectual curiosity about technology and new ways of working, coupled with a collaborative and open mindset.
Willingness to travel to our international manufacturing sites and work side-by-side with site teams on highly complex issues

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 (e.g., Small Molecules Operations Units, network strategy), 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.