Sr. Director, Head of Process Engineering

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Job Description 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   will   be r esponsible for   o rganizational leadership   for   global   Process Engineering team within SMPD   and   for   driving   global   functional area strategy .   Accountable for the performance and results of   global Process Engineering   group; strategic influence across Takeda Business Units and/or with external collaborators .     Responsible for i dentification and application of relevant industry trends to inform operational strateg y, with an emphasis on e nterprise leadership , ensuring   success for current and future programs within   Process Engineering and SMPD broadly .   Represents   Takeda externally and drives external collaboration network strategy .   Provide 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 .   ACCOUNTABILITIES:   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 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 member s   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, quality by design ( QbD ), and risk management.   Builds   and   sustains   strategic relationships with academic partners, consortia, and vendors to access   cutting-edge   science and capabilities.   Maintains external visibility and thought leadership through publications, invited talks, and representation in industry working groups.   EDUCATION, EXPERIENCE AND SKILLS:   Bachelor’s degree in Chemical Engineering   and   25 + years relevant industry experience;   Master’s degree in Chemical Engineering   and   21 + years relevant industry experience; PhD in Chemical Engineering and 1 5 + years relevant industry experience.   Extensive experience in small molecule process development, scale-up, and commercialization.   Direct experience working in a manufacturing facility or pilot plant environment, with a strong understanding of cGMP operations, technology transfer, and scale-up.   Demonstrated leadership in facility design, start-up, or expansion projects, including defining user requirements, equipment   selection , and commissioning.   Demonstrated success in leading teams and managing technical staff.   Strong   track record   of contr