Sr. Director, Head of Process Engineering

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Cambridge, MA, USA
Hybrid
212K-333K Annually
Senior level
Healthtech • Software • Analytics • Biotech • Pharmaceutical • Manufacturing
Takeda exists to create better health for people, brighter future for the world.
The Role
Leads Takeda’s global Synthetic Molecule Process Engineering organization and strategy. Oversees process design, optimization, scale-up, technology transfer, facility and pilot plant initiatives, process safety, quality by design, regulatory support, and commercialization of small-molecule drug substances. Accountabilities include team leadership, talent development, organizational capability building, sourcing strategy, external partnerships, continuous manufacturing, and cross-functional collaboration across R&D, Quality, Regulatory, and manufacturing organizations.
Summary Generated by Built In

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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. 

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. 


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.

LocationsCambridge, MA

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull 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.

Skills Required

  • Bachelor’s degree in Chemical Engineering with 25+ years of relevant industry experience
  • Master’s degree in Chemical Engineering with 21+ years of relevant industry experience
  • PhD in Chemical Engineering with 15+ years of relevant industry experience
  • Extensive experience in small-molecule process development, scale-up, and commercialization
  • Direct experience in a manufacturing facility or pilot plant environment
  • Strong understanding of cGMP operations, technology transfer, and scale-up
  • Experience leading facility design, start-up, or expansion projects
  • Experience defining user requirements, selecting equipment, and commissioning facilities
  • Demonstrated success leading teams and managing technical staff
  • Strong track record contributing to regulatory filings, including IND/IMPD, NDA, and MAA submissions
  • Experience working with external partners, including CMOs/CDMOs, and managing complex technology transfers
  • Expertise in process analytical technologies, including FT-IR, NIR, FBRM, and UV-vis
  • Expertise in chemometrics and statistical or first-principles modeling
  • Experience with advanced process control strategies and continuous manufacturing
  • Strong background in crystallization, particle engineering, and polymorph control
  • Experience building new technical platforms and organizational capabilities
  • Experience with process safety evaluation, risk assessments, and pilot plant operations
  • Experience leading organizational change and continuous innovation
  • Proven scientific track record through conference presentations and peer-reviewed publications
  • Excellent written and verbal communication skills
  • Active professional network involvement and scientific leadership

Takeda Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.

  • Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
  • Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
  • Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.

Takeda Insights

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The Company
HQ: Cambridge, MA
50,000 Employees
Year Founded: 1781

What We Do

For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world.  We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts.   Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives.   Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.  

Why Work With Us

We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.

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