Associate Director, AQbD & Platform Analytical Methods

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

Job summary

Takeda in Lexington, MA seeks an Associate Director to lead Analytical Quality by Design and Platform Analytical Method Life Cycle. You will oversee strategy, governance, and lifecycle management across development, ensuring robust methods and regulatory readiness.

The role collaborates with QC, QA, Regulatory CMC, MSAT, and external labs in a global matrixed network. You will drive adoption of AQbD, develop risk-based assessment processes, and shape validation/transfer strategies while

Qualifications

• Experience applying AQbD principles across development stages.
• Deep understanding of analytical method lifecycle and risk assessment.
• Regulatory readiness and alignment with CQAs, control strategy and specs.
• Ability to lead cross-functional teams in a matrixed environment.

Responsibilities

• Implement AQbD standards and lifecycle management for methods.
• Lead platform methods strategy with standardization and governance.
• Drive cross-program assessments for method harmonization and transfer.
• Develop analytics lifecycle practices including monitoring and risk handling.
• Align analytical strategies with regulatory expectations and CQAs.
• Provide guidance on AQbD application, validation, and transfer readiness.
• Collaborate with QC, QA, MSAT, Regulatory CMC, and external labs.
• Support regulatory submissions and health authority responses.

Skills

AQbD principles

Analytical lifecycle

Regulatory readiness

Cross-functional collaboration

Education

BS in Analytical Chemistry / related

Job description

Takeda in Lexington, MA seeks an Associate Director to lead Analytical Quality by Design and Platform Analytical Method Life Cycle. You will oversee strategy, governance, and lifecycle management across development, ensuring robust methods and regulatory readiness.

The role collaborates with QC, QA, Regulatory CMC, MSAT, and external labs in a global matrixed network. You will drive adoption of AQbD, develop risk-based assessment processes, and shape validation/transfer strategies while