Analytical LCM Product Lead - Vaccines
About The Position
The Analytical LCM Product Lead is the single point of accountability for global analytical lifecycle management (LCM) of Takeda’s live-attenuated tetravalent dengue vaccine, manufactured in Vero cells and presented as a lyophilized drug product with diluent for reconstitution. The role owns the vaccine’s analytical LCM strategy across its commercial lifecycle and maintains the analytical roadmap and method risk register in alignment with the broader CMC program plan. The position integrates and oversees vaccine-specific analytical LCM activities, including analytical methods and control strategies, regulatory filings and specification justifications, technology transfer, method remediation, process changes, reference standards and key materials, virus seeds and cell banks, analytical change control, and comparability. It coordinates stakeholders across MSAT, Pharm Sci, Quality, Regulatory, GSQ, QC sites, IT, and internal and external laboratories to align priorities, resourcing, ways of working, and network strategy. The role ensures appropriate quality management, training, documentation, data integrity, and inspection readiness across the network. It also advances analytical technology innovation and digital-forward platforms, embedding risk-based thinking in method development, qualification, validation, and lifecycle management to improve robustness, reduce investigations, and accelerate technology transfer and comparability.
Requirements
- BS or MS in Microbiology, Virology, Immunology, Biochemistry, Biology, or a related discipline; a PhD is preferred.
- 10+ years of experience in pharma or biotech, with depth in Analytical Development and/or QC.
- Experience leading vaccine analytical programs in development and/or lifecycle management; live-attenuated viral vaccine experience is ideal.
- Proficiency across vaccine analytical technologies for drug substance and drug product, especially cell-based potency/infectivity assays, molecular methods such as qPCR/RT-PCR, and immunoassays.
- Significant people and matrix leadership experience, with accountability for commercial product strategy, governance, and delivery, including BLA/MAA filings and post-approval lifecycle management.
- Demonstrated experience developing analytical and holistic control strategies and supporting regulatory submissions, including 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 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 ability to manage complex priorities and stakeholders.
- Track record modernizing analytical platforms or scaling new ways of working.
Nice To Haves
- PhD in Microbiology, Virology, Immunology, Biochemistry, Biology, or a related discipline.
- Experience with live-attenuated viral vaccines.
Responsibilities
- Own global analytical lifecycle management for the dengue vaccine and serve as the single point of accountability for the analytical program.
- Develop and maintain the vaccine’s analytical LCM strategy, analytical plan, roadmap, and method risk register in alignment with the CMC program plan.
- Coordinate and integrate analytical LCM activities, including methods, regulatory filings, specification justifications, tech transfer, method remediation, process changes, reference standards and key materials, virus seeds and cell banks, change control, and comparability.
- Work with cross-functional and enterprise stakeholders to align scientific direction, priorities, resources, network strategy, and program roadmaps.
- Ensure appropriate quality management of analytical plans and methods across the network, including standards, training, data integrity, documentation, and inspection readiness.
- Monitor method performance and proactively implement measures to maintain control of the product and its analytical methods throughout their lifetime.
- Partner with QA, QC, Manufacturing/MSAT, Regulatory CMC, Supply Chain, and IT on submission-ready analytical sections, inspection readiness, and change-control and lifecycle-management governance.
- Drive adoption of analytical technology innovation and digital-forward platforms in collaboration with MSAT, QC laboratories, and other stakeholders.
- Build and maintain internal and external leadership networks to advance technical strategies, risk-based methods, platform modernization, and analytical capability.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
