Sr. Director, Head of Process Engineering

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.

About the role

The Sr. Director of Process Engineering will provide organizational leadership for the global Process Engineering team within SMPD and drive global functional area strategy. This role is accountable for the performance and results of the global Process Engineering group, with strategic influence across Takeda Business Units and external collaborators. The successful candidate will establish long-term technical vision, build organizational capability, and ensure alignment with pipeline needs and broader organizational objectives.

Responsibilities

• Define the long-term vision and strategic roadmap for SMPD global process engineering capabilities, ensuring alignment across SMPD departments, Pharm Sci functions, and 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.
• Lead development and manufacturing of full synthetic molecule development by leveraging process engineering expertise directly or through team leadership.
• Establish and manage operational processes across global Process Engineering within SMPD.
• Direct team members in process development and optimization for key unit operations, including reaction engineering, crystallization, particle engineering, separations, and drying.
• Oversee design, qualification, and operation of laboratory scale-down models to enable robust process scale-up.
• Develop and oversee strategies for global Process Engineering infrastructure, resources, projects, and implementation of relevant technologies and innovations.
• Manage performance, personnel issues, and communication effectiveness within global Process Engineering.
• Define and own sourcing strategy for process engineering development and contribute to overall strategy for synthetic molecule development and manufacture.
• Engage with leadership of SMPD departments, Pharm Sci functions, and other business units (Quality, Regulatory, GSQ) to align investigational synthetic molecule engineering strategies at operational, project, and portfolio levels.
• Identify and elevate awareness of initiatives with cross-R&D or cross-divisional impact.
• Lead complex, interdisciplinary initiatives and sponsor cross-departmental or cross-functional initiatives.
• Advise CMC teams on the impact of team actions on other projects and vice versa.
• Contribute to R&D and cross-Business Unit strategy to solve complex issues.
• Accountable for relevant technical content in regulatory filings (IND, NDA, MAA) and health authority queries.
• Establish and enforce best practices in process safety, quality by design (QbD), and risk management.
• Build and sustain strategic relationships with academic partners, consortia, and vendors to access cutting-edge science and capabilities.
• Maintain external visibility and thought leadership through publications, invited talks, and representation in industry working groups.

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 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 environments and leading others through change by creating an inspiring and engaging workplace.
• Proven ability to recommend, influence, and implement organizational change and continuous innovation.
• Proven scientific track record through presentations at scientific conferences and publication of peer-reviewed manuscripts.

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 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.

Schedule

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

Pay

U.S. Base Salary Range: $212,000.00 - $333,190.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on qualifications, experience, skills, education, location, and other factors.

U.S. based employees may be eligible for short-term and/or long-term incentives.

Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per calendar year.
• New hires eligible to accrue up to 120 hours of paid vacation.

May require approximately 5-10% travel.

Location: Cambridge, MA