Sr. Director, Head of Process Engineering

Takeda; Cambridge (MA); Hybrid; USD 212,000 - 333,000; Full time

Job summary

Takeda in Cambridge, MA is seeking a senior leader to define and drive the global Process Engineering strategy for small molecule development within SMPD. You will lead cross-functional teams across production, QA, regulatory, and external partners to ensure scalable, compliant processes from discovery to commercialization.

The role requires extensive experience in small molecule process development, scale-up, and cGMP manufacturing, with a proven track record in driving innovations, technical

Qualifications

• Bachelor’s degree in Chemical Engineering with extensive industry experience (25+ years for BS, 21+ for MS, 15+ for PhD).
• Extensive small molecule process development, scale-up, and commercialization experience.
• Direct experience in manufacturing or pilot plants with cGMP, tech transfer, and scale-up.

Responsibilities

• Define long-term vision and roadmap for SMPD global process engineering capabilities.
• Lead global Process Engineering operations and performance management.
• Oversee design, qualification, and operation of lab scale-down models for scale-up.
• Spearhead strategies for global Process Engineering infrastructure and innovations.
• Advise on regulatory filings and cross-business unit alignment.

Skills

Leadership

Strategic Vision

Technical Depth

Communication

Collaboration

Problem-Solving

External Engagement

Education

Bachelor’s in Chemical Engineering

25+ years relevant experience

Graduate degree preferred (MS/PhD)

Tools

Process analytics (FT-IR, NIR)

Chemometrics

Modeling (statistical/first principles)

Job description

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.

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 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.

For information about our benefits, please click here.

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

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

YesIt 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.