Senior Analytical LCM Portfolio Lead

Takeda Pharmaceutical Co.; Lexington (MA); On-site; USD 212,000 - 333,000; Full time

Job summary

Takeda is seeking a senior Analytical LCM leader based in Lexington, MA to drive standardized governance across analytical development and lifecycle management, coordinating with QA, QC, Regulatory CMC, and IT to ensure submission-ready sections and inspection readiness.

The role emphasizes AQbD, risk-based validation, cross-modality portfolio planning, and roadmap governance, with accountability for strategy, resourcing, and partner alignment across internal and external labs.

Qualifications

• BS/MS in Chemistry or Pharmaceutical Sciences; PhD preferred.
• 12+ years in pharma/biotech with Analytical Development and/or QC leadership across multiple programs.
• Experience supporting regulatory submissions (IND/IMPD/BLA/NDA/MAA) and lifecycle strategies.

Responsibilities

• Define and drive the global Analytical LCM portfolio strategy and governance.
• Provide leadership for cross-modality analytical programs and risk-based decision making.
• Oversee resourcing and prioritization across internal and external labs.
• Collaborate with QA, QC, Regulatory CMC, IT, and Supply Chain to ensure submission-readiness and inspection readiness.

Skills

Analytical leadership

Stakeholder management

Regulatory collaboration

AQbD / risk-based validation

Lifecycle management

Education

BS/MS in Chemistry or Pharmaceutical Sciences

PhD preferred

Tools

CDS / LIMS / ELN

Job description

Takeda is seeking a senior Analytical LCM leader based in Lexington, MA to drive standardized governance across analytical development and lifecycle management, coordinating with QA, QC, Regulatory CMC, and IT to ensure submission-ready sections and inspection readiness.

The role emphasizes AQbD, risk-based validation, cross-modality portfolio planning, and roadmap governance, with accountability for strategy, resourcing, and partner alignment across internal and external labs.