Strategic Analytical LCM Portfolio Lead

USA - 3345 Takeda Manufacturing U.S.A., Inc; Lexington (MA); Vor Ort; USD 212.000 - 333.000; Vollzeit

Zusammenfassung

Takeda in Lexington, MA seeks a senior leader to own and drive Analytical LCM Portfolio Standardization & Governance across modalities, ensuring robust scientific direction and accountable program delivery.

You will establish risk-based, AQbD-driven strategies, oversee resourcing, and collaborate with QA, QC, Regulatory CMC, and IT to support submission-ready documentation and lifecycle management across the network.

Qualifikationen

• 12+ years in pharma/biotech with depth in Analytical Development and/or QC.
• Experience leading strategy, governance, and delivery across multiple programs including NDA/BLA.
• AQbD, risk-based validation/verification, and lifecycle management.
• Experience supporting regulatory submissions.
• Strong communication and stakeholder management.
• Track record modernizing analytical platforms.

Aufgaben

• Lead standardization and governance of Analytical LCM portfolio across modalities.
• Provide leadership for Analytical LCM Program representatives with clear accountability.
• Coordinate cross-functional resourcing and strategic portfolio planning.
• Collaborate with QA, QC, Manufacturing, Regulatory CMC, and IT to ensure readiness.

Kenntnisse

Analytical development

QC oversight

Regulatory submissions

Cross-functional leadership

People management

Ausbildung

BS/MS in Chemistry/Pharmaceutical Sciences

PhD preferred

Tools

CDS/LIMS/ELN

Jobbeschreibung

Takeda in Lexington, MA seeks a senior leader to own and drive Analytical LCM Portfolio Standardization & Governance across modalities, ensuring robust scientific direction and accountable program delivery.

You will establish risk-based, AQbD-driven strategies, oversee resourcing, and collaborate with QA, QC, Regulatory CMC, and IT to support submission-ready documentation and lifecycle management across the network.