Associate Director, AQbD & Platform Analytical Methods

USA - 3316 Takeda Development Center Americas, Inc.; Lexington (MA); Hybrid; USD 154,000 - 243,000; Full time

Benefits offered by this job

Hybrid work policy

Job summary

Takeda in Lexington, MA is seeking an Associate Director to lead Analytical Quality by Design and Platform Analytical Method Life Cycle. You will drive AQbD adoption, platform method governance, and lifecycle monitoring across development programs, partnering with AD, PD, QC, QA, and Regulatory teams.

You will shape strategy, provide technical risk assessments, enable robust method transfers, and support regulatory submissions. Fluency in English is required; Japanese is an asset.

Qualifications

• Experience applying AQbD in analytical development and lifecycle management.
• Ability to lead cross-functional teams and influence without direct authority.
• Knowledge of regulatory expectations for analytical method validation and lifecycle.
• Strong written and verbal communication for regulatory narratives.

Responsibilities

• Implement AQbD standards for method development and lifecycle management.
• Lead platform analytical methods strategy across programs and networks.
• Provide technical guidance on risk assessments, validation, and transfer readiness.
• Collaborate with QC, QA, Regulatory, and external labs to ensure consistency.
• Support regulatory submissions and health authority inquiries with data-driven narratives.
• Develop metrics and governance to monitor method adoption and performance.

Skills

AQbD expertise

Method lifecycle

Regulatory readiness

Cross-functional leadership

Project governance

Analytical chemistry

Education

BS in Analytical Chemistry

MS in Analytical Chemistry

PhD in Analytical Chemistry

Job description

Takeda in Lexington, MA is seeking an Associate Director to lead Analytical Quality by Design and Platform Analytical Method Life Cycle. You will drive AQbD adoption, platform method governance, and lifecycle monitoring across development programs, partnering with AD, PD, QC, QA, and Regulatory teams.

You will shape strategy, provide technical risk assessments, enable robust method transfers, and support regulatory submissions. Fluency in English is required; Japanese is an asset.