Analytical LCM Portfolio Lead – Synthetic Molecules

Takeda; Lexington (MA); In loco; USD 212.000 - 333.000; Tempo pieno

Descrizione del lavoro

Takeda is seeking an experienced Senior Analytical LCM Leader for the Synthetic Molecules portfolio in Lexington, MA. The role encompasses owning global program strategies, driving cross-functional collaboration, and delivering robust analytical control strategies throughout development to lifecycle.

Strong leadership, regulatory experience, and AQbD expertise are essential. In this capacity you will influence governance, tech-forward analytics, and lifecycle management across multiple programs,

Competenze

• 12+ years in pharma/biotech with analytical development or QC leadership.
• Experience supporting NDA/IMPD/BLA/IND regulatory submissions.
• Strong knowledge of separation sciences and dissolution.
• Proven ability to lead multiple analytical programs across a portfolio.
• AQbD, risk-based validation, and lifecycle management expertise.

Mansioni

• Own global Analytical LCM portfolio strategy for synthetic molecules.
• Provide scientific direction and governance across program leads.
• Collaborate with QA, QC, Regulatory and IT to align plans.
• Drive analytical technology innovation and platform modernization.
• Ensure regulatory readiness and data integrity across programs.

Conoscenze

Analytical leadership

Regulatory submissions

AQbD / risk-based validation

Analytical platforms oversight

Formazione

BS/MS in Chemistry/Pharmaceutical Sciences (PhD preferred)

Strumenti

CDS/LIMS/ELN

Descrizione del lavoro

Takeda is seeking an experienced Senior Analytical LCM Leader for the Synthetic Molecules portfolio in Lexington, MA. The role encompasses owning global program strategies, driving cross-functional collaboration, and delivering robust analytical control strategies throughout development to lifecycle.

Strong leadership, regulatory experience, and AQbD expertise are essential. In this capacity you will influence governance, tech-forward analytics, and lifecycle management across multiple programs,