Senior Analytical LCM Portfolio Lead: Synthetic Molecules

Takeda Pharmaceutical Company Limited; Lexington (MA); Sur place; USD 212 000 - 333 000; Plein temps

Résumé du poste

Takeda Pharmaceutical Company Limited in Lexington, MA is seeking a Senior Analytical LCM Leader for Synthetic Molecules to drive strategy and governance across global programs. You will provide direct scientific leadership, develop roadmaps, manage method risk, and collaborate with QA, QC, Regulatory, IT, and PharmSci to ensure lifecycle management and filing readiness.

The role emphasizes AQbD, risk-based thinking, and platform modernization, with extensive leadership across multiple analytic

Qualifications

• Education: BS/MS in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline; PhD preferred.
• Experience: 12+ years in pharma/biotech with depth in Analytical Development and/or QC, leading multiple SM analytical programs in development and/or lifecycle management.
• Proficient across analytical technology for API and drug product, including separation sciences and dissolution.
• Significant people and matrix leadership experience with governance and delivery across multiple programs incl. NDA/BLA filings.
• Control strategies & regulatory submissions experience (IND/IMPD/BLA/NDA/MAA).
• AQbD, validation/verification, robustness, and lifecycle management knowledge.
• Analytical platforms & informatics across CDS/LIMS/ELN in regulated environments.
• Regulatory support experience and strong stakeholder management.

Responsabilités

• Owns and drives Analytical LCM Portfolio Strategies for SM Programs across late development to commercial.
• Lead cross-functional teams and maintain program roadmaps and risk registers.
• Coordinate with QA, QC, Manufacturing/MSAT, Regulatory CMC, IT to ensure readiness and integration.
• Oversee method risk registers and drive continuous improvement for control strategies across lifecycles.

Connaissances

Matrix leadership

Stakeholder mgmt

Regulatory submissions

AQbD

Analytical development

Program governance

Communication

Platform modernization

Formation

BS/MS in Chemistry

PhD preferred

Outils

CDS

LIMS

ELN

Description du poste

Takeda Pharmaceutical Company Limited in Lexington, MA is seeking a Senior Analytical LCM Leader for Synthetic Molecules to drive strategy and governance across global programs. You will provide direct scientific leadership, develop roadmaps, manage method risk, and collaborate with QA, QC, Regulatory, IT, and PharmSci to ensure lifecycle management and filing readiness.

The role emphasizes AQbD, risk-based thinking, and platform modernization, with extensive leadership across multiple analytic