Associate Director, AQbD & Platform 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

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