Analytical LCM Portfolio Lead: Strategy & Governance

Takeda

Lexington (MA)

On-site

USD 212,000 - 333,000

Full time

2 days ago

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Job summary

Takeda in Lexington, MA is seeking a senior Analytical LCM Portfolio Leader to drive governance and standardization across modalities. You will lead strategic portfolio direction, align analytics with development and regulatory needs, and supervise resource allocation for multiple programs.

You will partner with QA, QC, Manufacturing, Regulatory CMC, and IT to ensure submission-ready sections, inspection readiness, and rigorous lifecycle management across the network.

Qualifications

12+ years in pharma/biotech with Analytical Development and/or QC leadership.
Experience supporting regulatory submissions (IND/IMPD/BLA/NDA).
Strong cross-functional collaboration and program leadership.

Responsibilities

Owns and drives Analytical LCM Portfolio Strategy and governance.
Standardizes risk registers and maintains methods/specifications.
Oversees resourcing across internal and external labs.
Interfaces with QA, QC, Manufacturing, Regulatory, and IT for lifecycle management.
Drives portfolio excellence, knowledge management, and metrics.
Embed AQbD and risk-based thinking in development and transfer.
Ensure submission-ready analytical sections and inspection readiness.
Lead cross-modality portfolio planning for new APIs and processes.

Skills

Leadership

Stakeholder mgmt

Regulatory support

AQbD

Validation

Education

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

Tools

CDS/LIMS/ELN

Job description

You will partner with QA, QC, Manufacturing, Regulatory CMC, and IT to ensure submission-ready sections, inspection readiness, and rigorous lifecycle management across the network.

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