Associate Director, Analytical Quality Design and Platform Analytical Method Lifecycle

Associate Director, Analytical Quality by Design and Platform Analytical Method Life Cycle

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…