Head of Analytical LCM Central Technology Laboratory

USA - 3345 Takeda Manufacturing U.S.A., Inc; Lexington (MA); Presencial; USD 212 000 - 333 000; Tempo integral

Resumo da oferta

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Technical leadership

GMP compliance

Analytical chemistry

Leadership

AQbD

Communication

Stakeholder management

Formação académica

BS/MS in Analytical Chemistry or related field

PhD preferred

Ferramentas

LIMS

ELN

CDS

Descrição da oferta de emprego

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 PharmSci 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, monitoring method performance and proactively implementing measures to ensure products and methods remain in control for the lifetime of use. Partner 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 execution of advanced analytics and the introduction and scaling of new analytical technology in alignment with established technology roadmaps and enterprise prioritization, including the 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 to improve robustness, reduce investigations and accelerate tech transfer and comparability.

Minimum Requirements/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 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.

Laboratory leadership & operations: Demonstrated experience leading GMP analytical laboratories — method lifecycle, capacity and resourcing, instrumentation and automation, data integrity, and inspection readiness.

AQbD / validation & lifecycle: Strong understanding of ICH expectations and practical execution of AQbD, risk‑based validation/verification, robustness, and method lifecycle management.

Analytical platforms & informatics: Strong technical oversight across all analytical modalities and technologies and enabling systems (CDS/LIMS/ELN), including standardization, automation, and qualification in regulated environments.

Deep characterization & comparability: Experience leading extended/deep product characterization, comparability, and working cell bank qualification across modalities.

Inspection readiness & compliance: Experience supporting regulatory submissions, inspections, and approval processes from a laboratory and data‑integrity perspective.

Scientific leadership & stakeholder management: Strong communication/collaboration; able to manage complex priorities, resourcing tradeoffs, and stakeholders across functions and regions.

Technology & automation: Track record introducing new analytical technology, automation, and advanced analytics or scaling new ways of working.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location: Lexington, MA U.S.

Base Salary Range: $212,000.00 - $333,190.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations Lexington, MA

Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes

Additional Company Information

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.