Associate Director - Process Analytics Lead (US)

Takeda; Lexington (MA); On-site; USD 154,000 - 243,000; Full time

Job summary

Takeda in Lexington, MA is hiring Associate Director - Process Analytics Lead to drive method development and platform implementation across small molecules and biologics. You will shape high-throughput analytical methods, support automation and robotics, and build scalable, compliant workflows with data integrity and execution consistency.

You will partner with Process Development, Quality, Compliance, Digital, IT and vendors to align priorities, lead multi-year roadmaps, oversee method

Qualifications

• 8+ years in analytical development/process analytics or related field.
• Degree in a relevant scientific or engineering discipline; advanced degree preferred.
• Proven experience designing and scaling automation solutions across workflows and sites.
• Experience deploying robotics-enabled high-throughput analytical workflows; method transfer and validation.
• Strong governance and AQbD method frameworks; performance metrics.
• Experience bridging high-throughput methods to GMP release/stability.
• People/matrix leadership; mentoring and cross-program influence.
• Ability to partner with senior scientific stakeholders to scale automation.
• Fluent English; Japanese a plus.

Responsibilities

• Lead development, optimization, and sustainment of high-throughput analytical methods across programs and product types.
• Define standards, performance measures, and governance for method lifecycle management.
• Ensure transfer, training, and implementation of methods into labs with documentation and troubleshooting plans.
• Deliver platform roadmap with automated analytical methods and workflows including robotics.
• Support vendor selection and management for automation platforms; drive cross-site standardization.
• Lead multi-year roadmaps for analytical development and automation; manage risks and value delivery.
• Modernize lab operations: data management, instrument connectivity, workflow standardization.
• Provide technical and people leadership to Process Analytics Development.

Skills

High-throughput analytics

Analytical method development

Leadership/people management

GMP/regulated environments

Stakeholder influence

Automation & robotics

Cross-functional collaboration

Strategic roadmaps

AQbD

Education

Bachelor's/Master's/PhD in Chemistry, Biochemistry, Pharmaceutical Sciences or Chemical Engineering

Tools

Robotics

Automation platforms

AQbD frameworks

Job description

Job Description

About the role:

The Associate Director - Process Analytics Lead is responsible for leading process analytics method development and platform implementation across multiple programs and product types within Analytical Development. In this role, you will shape high-throughput, fit-for-purpose analytical methods, support automation and robotics, and help build standardized ways of working that improve productivity, data integrity, and execution consistency. You will partner with Process Development, Quality, Compliance, Digital, Information Technology, and external vendors to align priorities, support delivery, and build scalable capabilities.

How you will contribute:

• Lead the development, optimization, and sustainment of high-throughput analytical methods for process and product development across small molecule and biologic programs, using phase-appropriate approaches and analytical quality by design principles.
• Define standards, performance measures, and governance for method lifecycle management within your area of responsibility.
• Ensure successful transfer, training, and implementation of developed methods into process development laboratories, including clear documentation, troubleshooting plans, and ongoing support for consistent non-good manufacturing practice platforms.
• Work with the Process Analytical Development team to deliver the platform roadmap, including automated analytical methods and end-to-end workflows with robotics where appropriate.
• Support vendor selection and vendor management for automation and analytical platforms, and help drive cross-site standardization.
• Lead strategy and multi-year roadmaps for analytical development and automation within the function, aligning priorities across partners and managing risks, trade-offs, and value delivery.
• Modernize laboratory operations, including sample and data management, instrument connectivity, workflow standardization, and data traceability.
• Provide technical and people leadership to the Process Analytics Development capability area through planning, prioritization, coaching, and change adoption.
• Lead cross-functional workstreams, resolve dependencies, and represent Analytical Development organization in governance and collaboration forums.

What you bring to Takeda:

• Typically 8 to 12 or more years of relevant industry or laboratory experience in analytical development or process analytics, with demonstrated delivery of high-throughput methods and or automation and process analytical technology implementations.
• Degree in a relevant scientific or engineering field such as Chemistry, Biochemistry, Pharmaceutical Sciences, or Chemical Engineering; bachelor’s, master’s, or doctorate accepted, with level and scope calibrated to degree and experience.
• Proven experience designing and scaling automation solutions across workflows, teams, and or sites, with measurable performance outcomes.
• Demonstrated experience deploying robotics-enabled high-throughput analytical workflows, including method transfer and validation considerations, assay robustness, and operational use in a research and development laboratory environment.
• Strong experience with analytical development strategy, standards, and governance, including analytical quality by design (AQbD) method frameworks and performance measures.
• Demonstrated ability to bridge high-throughput methods to GMP release and stability methods in partnership with Quality and Process Development teams.
• Demonstrated people and matrix leadership experience, including mentoring, coaching, prioritization across multiple programs, and influence with senior stakeholders; direct people management experience is preferred.
• Strong ability to partner with and influence senior scientific stakeholders, translating scientific needs into scalable automation and operating model solutions.
• Fluent in English; fluent in Japanese is a plus.
• Experience operating in regulated environments with automation, process analytical technology, and inspection readiness expectations is desirable.
• Familiarity with automation and artificial intelligence-assisted knowledge work within appropriate compliance constraints is desirable.

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:

Lexington, MA

U.S. Base Salary Range:

$154,400.00 - $242,550.00

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

Lexington, 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.