Strategic Global Analytical LCM Portfolio Lead

Takeda Pharmaceutical Company Limited; Lexington (MA); On-site; USD 200,000 - 333,000; Full time

Job summary

Takeda Pharmaceutical Company Limited in Lexington, MA seeks an experienced Analytical LCM leader to standardize governance across modalities, drive method development and lifecycle management, and align cross-functional teams on risk-based analyses. The role requires deep experience in analytical development, regulatory filings, and platform modernization.

You will partner with QA, QC, MSAT, Regulatory CMC, and IT to ensure submission-ready sections and lifecycle governance, shaping global

Qualifications

• Education: BS/MS in Chemistry, Pharmaceutical Sciences (PhD preferred).
• Experience: 12+ years in pharma/biotech with Analytical Development or QC leadership.
• Control strategy & regulatory filings: experience with IND/IMPD/MAA submissions.
• AQbD, validation, lifecycle: strong understanding and practical execution.
• Analytical platforms & informatics: oversight across modalities in regulated env.
• Analytical development breadth: support from discovery to regulatory submissions.
• Regulatory support: experience supporting regulatory submissions and approvals.
• Leadership & stakeholder mgmt: visible leadership and cross-functional influence.

Responsibilities

• Define and govern global Analytical LCM Portfolio strategy and roadmaps.
• Standardize governance across modalities for methods, specs, and risk.
• Oversee resourcing and prioritization of analytical work across labs.
• Interface with cross-functional stakeholders on portfolio planning and AQbD.
• Embed risk-based thinking in method development, qualification, and transfer.

Skills

Analytical leadership

Cross-functional collaboration

Regulatory readiness

Strategic thinking

Education

BS/MS in Chemistry/Pharmaceutical Sciences

Tools

CDS

LIMS

ELN

Job description

Takeda Pharmaceutical Company Limited in Lexington, MA seeks an experienced Analytical LCM leader to standardize governance across modalities, drive method development and lifecycle management, and align cross-functional teams on risk-based analyses. The role requires deep experience in analytical development, regulatory filings, and platform modernization.

You will partner with QA, QC, MSAT, Regulatory CMC, and IT to ensure submission-ready sections and lifecycle governance, shaping global