Head of Analytical LCM Technology Laboratory Job Lexington area,Massachusetts USA,Quality Assurance

Job Description

About the role:

Central Technology Laboratory Leadership: Single point of accountability for Takeda's Analytical LCM Central Technology Laboratory - a US-based central laboratory serving all modalities (small molecules, biologics, vaccines, and plasma-derived therapies) and a Japan-based regional laboratory dedicated to vaccines analytical testing. Leads to deliver deep technical, high-quality, and compliant analytical execution.
Very strong technical leadership across all analytical technologies and modalities: Authoritative technical leadership across the full breadth of analytical technologies - chromatography & mass spectrometry; spectroscopy, biophysical & physicochemical; bioassays, cell-based potency & ligand binding; and microbiology & molecular safety - ensuring GMP method performance, specialized testing and deep characterization, and the introduction of new technology. Provides direct line-functional leadership for the laboratory organization, ensuring consistent scientific direction, work prioritization, capability building, and clear accountability for laboratory deliverables.
Resourcing & Enterprise Prioritization Leader working in strong collaboration and communication with the Analytical LCM Portfolio Lead, the Analytical LCM Modality Leads, MSAT Manufacturing Leads, Pharm Sci Analytical, QC sites and internal and external analytical labs and services to ensure all laboratory work is appropriately resourced and to align on prioritization, capacity, network strategy, technology plans, and analytical lab work resourcing across the US central and Japan regional laboratories.
Tech Forward: Driving towards digital-forward analytical technology innovation and platforming embedment in analytical methodology and laboratory operations. Working in collaboration with key stakeholders from Pharm Sci to QC labs, including quality and regulatory and IT to introduce, qualify, and scale the latest analytical technology and advanced analytics into routine GMP execution.
Strong people leader for a multi-manager laboratory organization, building technical capability, succession, and an inclusive high-performance culture across the central and regional laboratories. Embed AQbD and risk-based thinking in method development, qualification/validation, and lifecycle management to improve robustness, reduce investigations, and accelerate tech transfer and comparability.

How you will contribute:

Accountable for the operations, performance, compliance, and resourcing of the US-based Analytical LCM Central Technology Laboratory (all modalities) and the Japan-based regional laboratory (vaccines analytical testing only), ensuring GMP method performance, data integrity, and inspection readiness.
Leads and develops an organization spanning lab-facing modality-agnostic technical SMEs, hands-on lab SMEs, and platform technical experts. Builds capability, succession, and an inclusive, high-performance culture, and ensures the laboratory is appropriately staffed and resourced to meet enterprise demand.
Strong interface & communication with the Analytical LCM Portfolio Lead, the Analytical LCM Modality Leads, MSAT Analytical, MSAT manufacturing, Pharm Sci, Quality, Regulatory, GSQ, QC sites, and IT to align on prioritization, resourcing, capacity, and technology plans, and to ensure laboratory work is well integrated and resourced into existing and future control strategies.
Accountable for the integrated planning and execution of all centralized analytical laboratory activities - GMP method performance, specialized testing and deep characterization, extended product and key-material characterization, comparability, working cell bank (WCB) qualification, reference-standard and key-material testing, analytical change control and technical execution support. Ultimately accountable for the laboratory’s analytical plans and the quality and timeliness of their execution.
Leads right-first-time (RFT) industrialization of GMP assays - improving method robustness and throughput, troubleshooting investigations, and supporting method tech transfer with hands-on technical execution support to sites and CMOs. Ensures laboratory plans and methods have appropriate quality management across the network, including standards, training, and inspection readiness expectations for data integrity and documentation practices.
Drives assay development, qualification, transfer, and troubleshooting across analytical platforms and supports QC readiness,…