Sr. Director, Head of Process Engineering

Takeda•Cambridge, MA

9d•Hybrid

About The Position

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 responsible for organizational 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 identification and application of relevant industry trends to inform operational strategy, with an 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. 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.

Requirements

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 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, equipment selection, and commissioning.
Demonstrated success in leading teams and managing technical staff.
Strong track record of contributions to regulatory filings (IND/IMPD, NDA, MAA), including late-stage submissions.
Significant experience in working with external partners (CMOs/CDMOs) and managing complex technology transfers.
Expertise in 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.
Prior success 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 creating and inspiring and engaging workplace.
Experience recommending, influencing and implementing organizational change and continuous innovation.
Proven scientific track record through presentations at scientific conferences and publication of peer-reviewed manuscripts.
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 matter expertise in 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.

Responsibilities

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 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, 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.