OBJECTIVE:
Synthetic Molecule Process Development (SMPD)is responsible fordeveloping robust, sustainable, and cost-effective processes for the manufacture of new synthetic molecule pharmaceuticals, ensuringhigh standardsof quality, safety, and scalability.
The Sr. Director ofProcessEngineeringwillbe responsible fororganizational leadershipforglobalProcess Engineering team within SMPDandfordrivingglobalfunctional area strategy.Accountable for the performance and results ofglobal Process Engineeringgroup; strategic influence across Takeda Business Units and/or with external collaborators.Responsible for identification and application of relevant industry trends to inform operational strategy, with an emphasis on enterprise leadership, ensuringsuccess for current and future programs withinProcess Engineering and SMPD broadly.RepresentsTakeda 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 forestablishinglong-term technical vision, building organizational capability, and ensuring alignment with both pipeline needs and broader organizationalobjectives.
ACCOUNTABILITIES:
- Defines the long-term vision and strategic roadmap forSMPDglobalprocess engineering capabilities, ensuring alignmentacross 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 fordevelopment and manufacturing offull synthetic moleculedevelopmentin terms ofleveragingprocess engineeringexpertiseeither directly or through leadership of team members
- Establishes and manages operational processes acrossglobal Process Engineeringwithinglobal SMPD.
- Has full accountability for all engineering aspects forsmall moleculepipeline projects.
- Directsteam members inprocess development and optimization for key unit operations, including reaction engineering, crystallization, particle engineering, separations, and drying.
- Overseesdesign, qualification, and operation of laboratory scale-down models to enable robust process scale-up.
- Develops and oversees strategies forglobal Process Engineeringinfrastructure, resources, projects, etc. and implementsrelevanttechnologies and innovations.
- Manages performance, personnel issues, and communication effectivenesswithin global Process Engineering
- Accountable for the development of organizational culture and capabilities withinglobal Process Engineering and global SMPD.
- Defines and ownssourcingstrategy forprocess engineering developmentand contributes materially and may own aspects of overall strategy forsynthetic molecule development and manufacture.
- Contributes to wider cross Business Unit strategyparticularly with respect to Commercial (GSQ) development and manufacturing
- Engagesfrequentlywith leadership of SMPD departments and Pharm sci functions, and other business units (Quality, Regulatory, and GSQ) to ensure investigational synthetic moleculeengineeringstrategies are aligned at the operational workflow, Project, and Portfolio levels, where relevant.
- Identifiesand elevates awareness of topics for initiatives with impact across R&D/cross-divisionalorganization.
- 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 technicalexpertiseto contribute toR&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.
- Buildsandsustainsstrategic relationships with academic partners, consortia, and vendors to accesscutting-edgescience 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 Engineeringand25+ years relevant industry experience;Master’s degree in Chemical Engineeringand21+ years relevant industry experience; PhD in Chemical Engineering and 15+ 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, equipmentselection, and commissioning.
- Demonstrated success in leading teams and managing technical staff.
- Strongtrack recordof contributions to regulatory filings (IND/IMPD, NDA, MAA), including late-stage submissions.
- Significant experiencein working with external partners (CMOs/CDMOs) and managing complex technology transfers.
- Expertisein process analytical technologies (FT-IR, NIR, FBRM, UV-vis, etc.), chemometrics, and modeling (statistical and first principles).
- Experience with advanced process control strategies and continuous manufacturing.
- Strong background in crystallization, particle engineering, and polymorph control.
- Priorsuccess in building new technical platforms and organizational capabilities.
- Experience with process safety evaluation, risk assessments, and pilot plant operations.
- Experience navigating changing external and internal environment and leading others through change by creatingandinspiring and engaging workplace
- Experience recommending,influencingand implementing organizational change and continuous innovation
- Proven scientifictrack recordthrough presentations at scientific conferences and publication of peer-reviewed manuscripts.
Knowledge and Skills:
- Leadership: Proven ability to lead, mentor, and inspire high-performing technical teams.
- Strategic Vision: Ability to define and implement long-term technical and organizational strategies.
- Technical Depth: Recognized subject matterexpertisein process engineering, with broad knowledge across reaction engineering, particle science, and scale-up.
- Communication: Excellent written and verbal communication; able to influence across functions and present effectively to senior leadership and external stakeholders.
- Collaboration: Strong cross-functional teamwork; ability to build relationships internally and externally.
- Problem-Solving: Strong analytical, risk assessment, and decision-making skills.
- External Engagement: Active involvement in professional networks, with a record of publications, presentations, or scientific leadership in the field.
TRAVEL REQUIREMENTS:
May requireapproximately5-10% travel.
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
