Head of Analytical LCM Central Lab — Tech-Forward Leader

USA - 3345 Takeda Manufacturing U.S.A., Inc

Lexington (MA)

On-site

USD 212,000 - 333,000

Full time

3 days ago

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Job summary

Takeda in Lexington, MA is seeking a Senior Laboratory Leader to oversee the US Analytical LCM Central Technology Laboratory and a vaccines-focused regional lab. You will ensure GMP method performance, data integrity, and inspection readiness across multiple modalities.

The role requires extensive leadership experience, AQbD implementation, and cross-functional collaboration with QA, QC, Manufacturing, Regulatory, IT, and external labs to align on capacity, technology plans, and resource

Qualifications

Education: BS/MS in Analytical Chemistry, Biochemistry, Biology, Microbiology, or related discipline (PhD preferred).
Experience: 20+ years in pharma/biotech with depth in Analytical Development and/or QC, including GMP laboratory leadership.
Laboratory leadership & operations: Demonstrated experience leading GMP analytical laboratories and managing resources.

Responsibilities

Accountable for operations, performance, compliance, and resourcing of the US-based Analytical LCM Central Technology Laboratory and the Japan-based regional laboratory.
Leads and develops an organization spanning modality-agnostic technical SMEs, hands-on lab SMEs, and platform experts.
Drive AQbD, risk-based thinking in methods development, qualification/validation and lifecycle management.
Ensure data integrity and inspection readiness across the network of laboratories.