Associate Director, Analytical Quality by Design and Platform Analytical Method Lifecycle

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

Job summary

Takeda in Lexington, MA is seeking an Associate Director for Analytical Quality by Design and Platform Analytical Method Life Cycle. You will lead AQbD implementation, governance, and lifecycle management across development to regulatory readiness, partnering with QA, QC, and regulatory functions to drive robust method performance.

The role requires extensive experience in analytical development, risk assessments, and strategy across modalities, with strong influence and cross-functional

Qualifications

• BS with 15+ years of industry experience or higher degrees with corresponding years.
• Deep understanding of analytical development across modalities and regulatory readiness.
• Experience governing analytical methods across programs and stages.
• Strong knowledge of ICH guidelines and lifecycle management.
• Practical experience implementing AQbD workflows and risk assessments.
• Ability to translate analytical risks into actionable recommendations.

Responsibilities

• Implement AQbD standards and lifecycle management for methods.
• Lead platform analytical methods strategy and governance.
• Drive cross-program assessments for standardization and transferability.
• Develop analytical control strategies and validation approaches.
• Support regulatory submissions and inspections with technical narratives.
• Establish metrics and continuous improvement for platform methods.

Skills

AQbD principles

Analytical lifecycle

Cross-functional leadership

Regulatory readiness

Risk assessment

Method development

Analytical strategy

Data analytics

Knowledge management

Education

BS in Analytical Chemistry or related with 15+ years

MS with 13+ years

PhD with 7+ years

Tools

ICH Q14

ICH Q2(R2)

AQbD workflows

Job description

Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Analytical Quality by Design and Platform Analytical Method Life Cycle in our Lexington, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

POSITION OBJECTIVES:

The Associate Director, Analytical Quality by Design and Platform Analytical Method Life Cycle plays a critical role in implementation of Analytical Quality by Design principles across Analytical Development to improve method robustness, analytical transfers, lifecycle management, and regulatory readiness. This person also serves as a technical and strategic lead for analytical method lifecycle practices, including risk assessments, method development expectations, validation/verification strategy, analytical transfer readiness, and continued method performance monitoring.

This role partners closely with AD, PD, QC, QA, Regulatory CMC, MSAT, and external laboratories to drive consistent, phase-appropriate analytical practices aligned with portfolio needs, holistic control strategy, and regulatory expectations.

You will own and manage implementation of the platform analytical methods strategy, including standardization, governance, lifecycle monitoring, and fit-for-purpose adoption across development programs and internal/external testing networks.

ACCOUNTABILITIES:

• Implement AQbD standards, templates, and ways of working for method development, optimization, robustness assessment, qualification, validation, transfer, and lifecycle management.

• Manage implementation of the platform analytical methods strategy, including method selection, standardization, lifecycle governance, and adoption across programs.

• Lead cross-program technical assessments to identify opportunities for platform methods, prior knowledge leverage, method harmonization, simplification, and improved transferability.

• Develop and maintain analytical lifecycle management practices, including method performance monitoring, risk-based change management, and issue escalation pathways.

• Partner with AD representatives to ensure analytical method strategies are aligned with CQAs, control strategy, specifications, stability plans, comparability requirements, and regulatory expectations.

• Provide technical guidance to project teams on AQbD application, method risk assessments, validation strategy, transfer readiness, and phase-appropriate analytical control.

• Work with QC, QA, MSAT, Regulatory CMC, and external laboratories to enable consistent execution of platform methods and lifecycle practices across the network. Operates in a matrixed global environment where analytical strategy decisions require alignment across AD, PD, QC, QA, Regulatory CMC, MSAT, external labs, and program teams.

• Support regulatory submissions, health authority responses, inspections, and internal governance reviews by contributing scientifically sound analytical strategy narratives and risk-based justifications.

• Establish metrics, knowledge management practices, and continuous improvement mechanisms to monitor platform method adoption, method robustness, transfer success, and lifecycle performance.

• Benchmark industry trends, regulatory expectations, and emerging technologies relevant to AQbD, analytical lifecycle management, and platform analytical methods.

• Drives adoption of standardized analytical practices through influence, governance, clear expectations, technical credibility, and pragmatic change management.

• Works with senior leaders to translate analytical strategy into executable standards, templates, decision frameworks, and implementation plans.

• Contributes to capability building through training, communities of practice, technical guidance, and coaching of project-facing scientists.

• Accountable for developing technical recommendations and implementation plans for AQbD and platform analytical method practices across defined areas of Analytical Development.

• Exercises independent judgment on method risk assessments, lifecycle strategy, platform suitability, standardization opportunities, and escalation of analytical risks.

• Evaluates emerging analytical technologies, digital tools, automation, and data analytics approaches that may improve method robustness, scalability, transferability, or lifecycle oversight.

• Promotes knowledge management and cross-program learning to strengthen analytical strategy and reduce avoidable investigations, rework, and late-stage method changes.

EDUCATION AND EXPERIENCE:

• BS in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biology, or related discipline with 15+ years relevant industry experience; MS with 13+ years relevant industry experience; or PhD with 7+ years relevant industry experience.

• Technical expertise with deep understanding of analytical development principles across small molecules, biologics, or relevant therapeutic modalities, with demonstrated ability to apply phase-appropriate analytical strategies from early development through commercial readiness.

• Experience developing, implementing, or governing analytical methods across multiple programs, platforms, modalities, or development stages.

• Strong understanding of ICH Q14 and ICH Q2(R2), and regulatory requirements relevant to analytical method validation, lifecycle management, specifications, stability, comparability, and control strategy.

• Practical experience implementing AQbD workflows, including Analytical Target Profile definition, risk assessment, identification of critical method parameters, structured robustness/DoE studies, method control strategy, validation strategy, and lifecycle performance monitoring.

• Experience developing or governing analytical control strategies, including alignment of CQAs, method capability, specifications, stability strategy, comparability requirements, and regulatory documentation.

• Ability to evaluate complex analytical data, method performance trends, investigations, transfer outcomes, and lifecycle risks to generate clear technical recommendations.

• Balance platform standardization with program-specific scientific, regulatory, modality, phase, and regional requirements.

• Supports analytical practices that directly affect regulatory submissions, method validation, commercial readiness, technology transfer, inspection readiness, and product control strategy.

• Demonstrated ability to lead cross-functional technical initiatives and drive implementation through influence rather than direct authority.

• Experience supporting regulatory submissions, health authority questions, inspections, or internal governance reviews.

• Strong scientific judgment, data interpretation skills, and ability to translate complex analytical risks into clear recommendations.

• Proven ability to work effectively in a multidisciplinary, global, and matrixed environment.

• Strong written and verbal communication skills, including ability to prepare standards, technical reports, governance materials, regulatory narratives, and executive-level recommendations.

• Structured, pragmatic, and execution-focused working style with ability to manage competing priorities across multiple programs.

• Proven ability to work cross-functionally at local and global levels.

• Fluent in English; Japanese is an asset.

Join us in shaping a best-in-class Analytical Development Portfolio by driving Analytical Quality by Design principles across Analytical Development to improve method robustness, analytical transfers, lifecycle management, and regulatory readiness. Serve as a technical and strategic lead for analytical method lifecycle practices, including risk assessments, method development expectations, validation/verification strategy, analytical transfer readiness, and continued method performance monitoring to ensure execution excellence across a diverse and dynamic global development portfolio.

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

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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

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

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.