Sr. Director, Head of Process Engineering

USA - 3316 Takeda Development Center Americas, Inc.; Cambridge (MA); Hybrid; USD 212,000 - 333,000; Full time

Job summary

Takeda is seeking a Sr. Director of Process Engineering in Cambridge, MA, to lead the global SMPD Process Engineering group and drive strategy across units.

You will guide process design, optimization, and technology transfer for small molecule drug substance operations through development and into commercial scale. The role requires extensive experience, excellent leadership, and the ability to coordinate with internal and external partners while maintaining cGMP, safety, and quality standards.

Qualifications

• Extensive experience in small molecule process development, scale-up, and commercialization.
• Proven leadership in facility design, startup or expansion projects.
• Strong track record in regulatory filings (IND/IMPD, NDA, MAA).

Responsibilities

• Define long-term vision and strategic roadmap for SMPD global process engineering.
• Lead global team performance, talent development, and cross-regional capability building.
• Oversee process design, scale-up, tech transfer for small molecules from pre-IND to PPQ and commercial.

Skills

Leadership

Strategic Vision

Technical Depth

Communication

Collaboration

Problem-Solving

External Engagement

Education

PhD in Chemical Engineering

Master’s degree in Chemical Engineering

Bachelor’s degree in Chemical Engineering

Job description

OBJECTIVE

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.

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 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.

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 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. 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 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.

TRAVEL REQUIREMENTS

May require approximately 5-10% travel. This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Cambridge, MA 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 a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations and Employment Details

Locations Cambridge, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Company Culture

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.