Senior Analytical LCM Product Lead

Takeda; Dublin; Vor Ort; EUR 120.000 - 180.000; Vollzeit

Zusammenfassung

Takeda seeks a senior analytical leader to oversee the global Analytical LCM portfolio for Synthetic Molecules. You will manage program leads, develop roadmaps, and ensure robust analytical control strategies across development and lifecycle stages.

This role requires extensive experience in analytical development, AQbD, and regulatory filings, with strong cross-functional collaboration to align quality and compliance across the network.

Qualifikationen

• Experience leading multiple analytical programs in development or lifecycle management.
• Strong understanding of AQbD, risk-based validation/verification, and method lifecycle management.
• Experience supporting regulatory submissions (IND/IMPD/BLA/NDA/MAA).

Aufgaben

• Act as single point of accountability for global Analytical LCM portfolio of Synthetic Molecules.
• Lead development of program plans, roadmaps, and risk registers across multiple programs.
• Collaborate with QA, QC, Manufacturing, Regulatory, and IT to ensure integrated plans and resources.
• Drive analytical technology innovation and AQbD adoption across networks to ensure quality outcomes.

Kenntnisse

Analytical Development

AQbD

Risk-based thinking

Leadership

Regulatory submissions

Strategic planning

Ausbildung

BS/MS in Chemistry or related field

Tools

CDS/LIMS/ELN

Jobbeschreibung

Takeda seeks a senior analytical leader to oversee the global Analytical LCM portfolio for Synthetic Molecules. You will manage program leads, develop roadmaps, and ensure robust analytical control strategies across development and lifecycle stages.

This role requires extensive experience in analytical development, AQbD, and regulatory filings, with strong cross-functional collaboration to align quality and compliance across the network.