Sr. Director, Head of Process Engineering

Overview

OBJECTIVE:
Synthetic Molecule Process Development (SMPD) is responsible for developing robust, sustainable, and cost-effective processes for the manufacture of new synthetic molecule pharmaceuticals, ensuring high standards of quality, safety, and scalability.

The Sr. Director of Process Engineering provides organizational leadership for the global Process Engineering team within SMPD and drives the global functional area strategy. Accountable for the performance and results of the global Process Engineering group; strategic influence across Takeda Business Units and/or with external collaborators. Responsible for identifying and applying relevant industry trends to inform operational strategy, with emphasis on enterprise leadership, ensuring success for current and future programs within Process Engineering and SMPD broadly.

Represents Takeda externally and drives external collaboration network strategy. Provides strategic and technical leadership for the global process engineering group, driving process design, optimization, and technology transfer for small molecule drug substance unit operations for the full development lifecycle from pre-IND to PPQ and Commercial tech transfer. The successful candidate will be accountable for establishing long-term technical vision, building organizational capability, and ensuring alignment with both pipeline needs and broader organizational objectives.

• Defines the long-term vision and strategic roadmap for SMPD global process engineering capabilities, ensuring alignment across SMPD departments and Pharm Sci functions, as well as other business units (Quality, Regulatory, GSQ).
• Accountable for the performance and results of the global team, including performance management, talent development, succession planning, and building organizational capability across global regions.
• Accountable for development and manufacturing of full synthetic molecule development in terms of leveraging process engineering expertise either directly or through leadership of team members.
• Establishes and manages operational processes across global Process Engineering within global SMPD.
• Has full accountability for all engineering aspects for small molecule pipeline projects.
• Directs team members in process development and optimization for key unit operations, including reaction engineering, crystallization, particle engineering, separations, and drying.
• Oversees design, qualification, and operation of laboratory scale-down models to enable robust process scale-up.
• Develops and oversees strategies for global Process Engineering infrastructure, resources, projects, etc. and implements relevant technologies and innovations.
• Manages performance, personnel issues, and communication effectiveness within global Process Engineering.
• Accountable for the development of organizational culture and capabilities within global Process Engineering and global SMPD.
• Defines and owns sourcing strategy for process engineering development and contributes materially and may own aspects of overall strategy for synthetic molecule development and manufacture.
• Contributes to wider cross Business Unit strategy particularly with respect to Commercial (GSQ) development and manufacturing.
• Engages frequently with leadership of SMPD departments and Pharm Sci functions, and other business units (Quality, Regulatory, and GSQ) to ensure investigational synthetic molecule engineering strategies are aligned at the operational workflow, Project, and Portfolio levels, where relevant.
• Identifies and elevates awareness of topics for initiatives with impact across R&D/cross-divisional organization.
• Leads complex, interdisciplinary initiatives and may sponsor a cross-departmental or cross-functional initiatives.
• Advises CMC teams on impact of team actions on other projects in their functional area and vice versa.
• Utilizes technical expertise to contribute to R&D/cross-Business Unit strategy to solve complex issues.
• Accountable for relevant technical content in regulatory filings (IND, NDA, MAA) and health authority queries.
• Establishes and enforces best practices in process safety,…