BS/MS in Analytical Chemistry, Biochemistry, Biology, Microbiology, or related discipline (PhD preferred)
20+ years in pharma/biotech with leadership in GMP analytical laboratories
Demonstrated experience in method lifecycle, capacity, and resourcing
Strong understanding of ICH expectations and AQbD principles
Experience in leading deep product characterization and comparability
Proven track record in regulatory submissions and inspection readiness
Strong communication and stakeholder management skills
Experience in introducing new analytical technology and automation
Responsibilities
Lead operations and compliance for US and Japan-based analytical laboratories
Develop and manage a multi-manager laboratory organization
Interface with cross-functional teams to align on laboratory priorities and resources
Oversee integrated planning and execution of centralized analytical activities
Drive right-first-time industrialization of GMP assays
Lead assay development and troubleshooting across analytical platforms
Partner with various departments to ensure consistency in analytical innovations
Accountable for scaling new analytical technology and advanced analytics
Benefits
Comprehensive health and wellness programs
Retirement savings plan with company match
Generous paid time off and holidays
Professional development and training opportunities
Flexible work arrangements and remote work options
Full Job Description
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 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.
For information about our benefits, please click here.
Locations Lexington, MA
Worker Type Employee
Worker Sub-Type Regular
Time Type Full time
Job Exempt Yes
About Takeda
Takeda Pharmaceutical Company Limited is a global pharmaceutical company that develops and markets pharmaceutical products. The company's products are used to treat a wide range of medical conditions, including cardiovascular and metabolic diseases, respiratory diseases, and cancer. Takeda Pharmaceutical Company Limited was founded in 1781 and is headquartered in Tokyo, Japan. The company has operations in more than 80 countries and employs more than 49,000 people worldwide.
