Analytical LCM Product Lead - Synthetic Molecules

Takeda•Lexington, MA

5d•$212,000 - $333,190

About The Position

The Analytical LCM Product Lead is the single point of accountability for Takeda’s global Analytical Lifecycle Management (LCM) portfolio of Synthetic Molecules, including traditional synthetic molecules, peptides, oligonucleotides, and linker payloads for ADCs. The role owns the portfolio strategy from late development through commercialization, with responsibility for integrating analytical program plans with overall CMC plans and ensuring appropriate analytical control strategies for the lifetime of each commercial product. The position provides direct people and functional leadership for analytical LCM program leads, setting consistent scientific direction, prioritization, accountability, and capability development. It oversees program roadmaps and method risk registers, and drives integrated planning and execution across methods, regulatory filings, specifications, technology transfer, remediation, process changes, reference standards, change control, comparability, and supply continuity. The role collaborates across MSAT, Pharmaceutical Sciences, Quality, Regulatory, GSQ, QC sites, Supply Chain, IT, and internal and external analytical laboratories. It ensures analytical methods and plans have appropriate quality management, documentation, training, data integrity, and inspection readiness. The Product Lead also advances analytical technology innovation, digital-forward platforms, AQbD, and risk-based approaches to improve method robustness, reduce investigations, and accelerate technology transfer and comparability.

Requirements

BS or MS in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline.
12 or more years of experience in pharma or biotech, with depth in Analytical Development and/or QC and experience leading multiple synthetic molecule analytical programs in development and/or lifecycle management.
Proficiency across synthetic molecule analytical technologies applied to API and drug product, especially separation sciences and dissolution.
Significant people and matrix leadership experience, with accountability for strategy, governance, and delivery across multiple programs, including NDA or BLA filings.
Demonstrated experience developing analytical and holistic control strategies and supporting regulatory submissions, including IND, IMPD, BLA, NDA, or MAA filings, specifications and justifications, stability, and comparability strategies.
Strong understanding of ICH expectations and practical execution of AQbD, risk-based validation or verification, robustness, and method lifecycle management.
Strong technical oversight across key analytical modalities and enabling systems such as CDS, LIMS, and ELN, including standardization and qualification in regulated environments.
Understanding of analytical development supporting discovery through manufacturing and regulatory submissions.
Experience supporting regulatory submissions and approval processes.
Strong communication and collaboration skills, with the ability to manage complex priorities and stakeholders.
Track record of modernizing analytical platforms or scaling new ways of working.

Nice To Haves

PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline.

Responsibilities

Serve as the single point of accountability for the global Analytical LCM portfolio of Synthetic Molecules.
Own and drive the Analytical LCM Synthetic Molecules portfolio strategy from late development through commercialization.
Provide direct people and functional leadership to analytical LCM program leads, ensuring consistent scientific direction, portfolio prioritization, capability building, and accountability.
Develop and maintain analytical program plans and roadmaps aligned with overall CMC program plans, including method risk registers.
Ensure analytical control strategies remain appropriate throughout the commercial product lifecycle through proactive planning and communication.
Lead integrated planning and execution of program-specific analytical LCM activities, including methods, regulatory filings, specification justifications, technology transfer, method remediation, process changes, reference standards, change control, and comparability strategies.
Work with enterprise leaders and cross-functional partners to integrate program needs and secure appropriate resources for analytical control strategies.
Coordinate with Pharmaceutical Sciences and Business Development to integrate incoming synthetic molecule analytical strategies into commercial lifecycle management.
Ensure analytical LCM plans and methods have appropriate quality management across the network, including standards, training, data integrity, documentation practices, and inspection readiness.
Monitor method risk registers and proactively implement measures to keep methods and products in control.
Partner with QA, QC, Manufacturing/MSAT, Regulatory CMC, Supply Chain, Pharmaceutical Sciences, and IT on submission-ready analytical sections, inspection readiness, and change-control and lifecycle governance.
Drive analytical technology innovation into program plans in collaboration with Pharmaceutical Sciences, the QC laboratory network, and other stakeholders.
Build and maintain internal and external enterprise leadership networks to advance sound technical strategies, AQbD, new technology, and risk-based method development, qualification, validation, and lifecycle management.