Analytical LCM Product Lead - Biologics

Takeda

6d•$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 for biologics, covering monoclonal antibodies, bispecific and multispecific antibodies, fusion proteins, recombinant proteins and enzymes, and antibody-drug conjugates. The role owns the portfolio strategy from late development through commercial and provides direct people and functional leadership to individual analytical LCM program leads. It ensures consistent scientific direction, portfolio prioritization, capability building, and accountability for program deliverables. The role oversees program strategies, roadmaps, and method risk registers aligned with broader CMC plans, and integrates analytical activities across methods, regulatory filings, specifications, tech transfer, remediation, process changes, supply continuity, and reference-standard and key-material control strategy bridging. It owns analytical change control and comparability strategy and is accountable for biologics program analytical plans and execution. Working across Pharm Sci, MSAT, Quality, Regulatory, GSQ, QC sites, Supply Chain, IT, and internal and external analytical labs, the role aligns analytical priorities, resources, network strategy, and ways of working. It advances digital-forward analytical technology and platform integration into lifecycle control strategies, and promotes AQbD and risk-based approaches in method development, qualification, validation, and lifecycle management. The role also supports submission readiness, inspection readiness, data integrity, documentation, and quality management across the network.

Requirements

BS or MS in Biochemistry, Biology, Biotechnology, Chemistry, Pharmaceutical Sciences, or a related discipline; a PhD is preferred.
12+ years of experience in pharma or biotech, with depth in Analytical Development and/or QC.
Experience leading multiple biologics analytical programs in development and/or lifecycle management.
Proficiency across biologics analytical technologies for drug substance and drug product, especially cell-based bioassay/potency methods, separation sciences, mass spectrometry, and biophysical and biochemical characterization.
Significant people and matrix leadership experience, with accountability for strategy, governance, and delivery across multiple programs, including BLA or MAA filings.
Demonstrated experience developing analytical and holistic control strategies and supporting regulatory submissions, including IND/IMPD/BLA/MAA submissions, specifications and justifications, stability, and comparability strategies.
Strong understanding of ICH expectations and practical execution of AQbD, risk-based validation/verification, robustness, and method lifecycle management.
Technical oversight across key biologics 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 Biochemistry, Biology, Biotechnology, Chemistry, Pharmaceutical Sciences, or a related discipline.

Responsibilities

Serve as the single point of accountability for the global Analytical LCM portfolio of biologics.
Own the Analytical LCM Biologics Portfolio Strategy from late development through commercial.
Provide direct people management and functional leadership for analytical LCM program leads and representatives.
Develop and maintain portfolio and program plans, analytical LCM roadmaps, and method risk registers aligned with CMC program plans.
Oversee analytical control strategies throughout the commercial product lifecycle, including methods, regulatory filings, specification justifications, stability, tech transfer, remediation, process changes, supply continuity, and reference-standard and key-material bridging.
Own analytical change control and comparability strategy and remain accountable for program analytical plans and execution.
Integrate analytical program plans and resources with enterprise leaders and teams across MSAT, Pharm Sci, Quality, Regulatory, GSQ, QC sites, Supply Chain, and IT.
Coordinate with Pharm Sci and Business Development to carry incoming biologics analytical strategies through into commercial lifecycle management.
Ensure appropriate quality management of analytical plans and methods across the network, including standards, training, data integrity, documentation, and inspection readiness.
Monitor method performance through program method risk registers and proactively implement measures to keep products and methods in control.
Partner with relevant functions to ensure submission-ready analytical sections, inspection readiness, and governance for change control and lifecycle management.
Drive analytical technology innovation and digital-forward platform embedment into biologics LCM plans in collaboration with Pharm Sci, QC labs, and other stakeholders.
Build and maintain internal and external enterprise leadership networks to advance sound technical strategies and embed AQbD, new technology, and risk-based thinking.