Head of Analytical LCM Central Technology Laboratory

Takeda•Lexington, MA

9d•$212,000 - $333,190•Onsite

About The Position

This role serves as the single point of accountability for Takeda’s Analytical LCM Central Technology Laboratory, which includes a US-based central laboratory supporting all modalities (small molecules, biologics, vaccines, and plasma-derived therapies) and a Japan-based regional laboratory focused on vaccines analytical testing. The position leads the delivery of deep technical expertise, high-quality results, and compliant analytical execution. It requires strong technical leadership across a wide range of analytical technologies, including chromatography & mass spectrometry, spectroscopy, biophysical & physicochemical methods, bioassays, cell-based potency & ligand binding assays, and microbiology & molecular safety testing. The role ensures GMP method performance, specialized testing, deep characterization, and the successful introduction of new technologies. It provides direct line-functional leadership for the laboratory organization, ensuring consistent scientific direction, effective work prioritization, capability development, and clear accountability for laboratory deliverables. Additionally, the role acts as a Resourcing & Enterprise Prioritization Leader, collaborating closely with various stakeholders to ensure adequate resourcing and alignment on prioritization, capacity, network strategy, technology plans, and analytical lab work across both US and Japan laboratories. A key focus is driving towards digital-forward analytical technology innovation and platform embedment in analytical methodology and laboratory operations, working with quality, regulatory, and IT to integrate new technologies into routine GMP execution. The role also emphasizes strong people leadership for a multi-manager organization, fostering technical capability, succession planning, and an inclusive, high-performance culture. It aims to embed Analytical Quality by Design (AQbD) and risk-based thinking to enhance method robustness, reduce investigations, and accelerate tech transfer and comparability.

Requirements

BS/MS in Analytical Chemistry, Biochemistry, Biology, Microbiology, or related discipline (PhD preferred).
20+ years in pharma/biotech with depth in Analytical Development and/or QC.
Significant leadership of GMP analytical laboratories and people managers (managers-of-managers).
Broad hands-on and oversight experience across the full range of analytical technologies and multiple modalities (small molecules, biologics, vaccines, and plasma-derived therapies).
Significant people and matrix leadership experience and accountability for laboratory operations, resourcing, and delivery in a GMP environment supporting regulatory filings and inspections.
Demonstrated experience leading GMP analytical laboratories — method lifecycle, capacity and resourcing, instrumentation and automation, data integrity, and inspection readiness.
Strong understanding of ICH expectations and practical execution of AQbD, risk-based validation/verification, robustness, and method lifecycle management.
Strong technical oversight across all analytical modalities and technologies and enabling systems (CDS/LIMS/ELN), including standardization, automation, and qualification in regulated environments.
Experience leading extended/deep product characterization, comparability, and working cell bank qualification across modalities.
Experience supporting regulatory submissions, inspections, and approval processes from a laboratory and data-integrity perspective.
Strong communication/collaboration skills; able to manage complex priorities, resourcing tradeoffs, and stakeholders across functions and regions.
Track record introducing new analytical technology, automation, and advanced analytics or scaling new ways of working.

Nice To Haves

PhD preferred.

Responsibilities

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, building capability, succession, and an inclusive, high-performance culture, and ensuring the laboratory is appropriately staffed and resourced to meet enterprise demand.
Serves as a strong interface and communication point with key stakeholders including the Analytical LCM Portfolio Lead, 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, ensuring 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, including 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.
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, ensuring laboratory plans and methods have appropriate quality management across the network.
Drives assay development, qualification, transfer, and troubleshooting across analytical platforms and supports QC readiness, monitoring method performance and proactively implementing measures to ensure products and methods remain in control for the lifetime of use.
Partners with QA, QC, Manufacturing/MSAT, Regulatory CMC, Supply Chain, Pharm Sci, and IT to ensure consistency in analytical and digital technology innovations and applications.
Accountable for the execution of advanced analytics and the introduction and scaling of new analytical technology in alignment with established technology roadmaps and enterprise prioritization, including MSAT centralized analytical lab operations, instrumentation estate, automation, capacity, and budget.
Builds and maintains a strong enterprise leadership network internally and externally to drive sound technical analytical strategies embedding AQbD, new technology, and risk-based thinking in methods development, qualification/validation, and lifecycle management.