Analytical LCM Product Lead - Vaccines

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While a primary location is identified for this role, qualified internal candidates in Lexington, Singen, Lessines, or Linz may also be considered, subject to business needs, role requirements, talent availability, and local legal requirements.

• Dengue vaccine LCM Analytical Oversight: Single point of accountability for the Analytical LCM of Dengue vaccine (dengue tetravalent vaccine).
• Owns and drives the Analytical LCM Strategy for Dengue vaccine: Deep understanding of the Dengue vaccine product control strategy and works with the analytical LCM team to ensure all analytical LCM activities are covered and on track with clearly defined roles and responsibilities, schedules and resources. Works to create and maintain the Dengue vaccine Analytical LCM roadmap and method risk register in alignment with the overall CMC program roadmap. Works cross functionally with Dengue vaccine team members to ensure consistent scientific direction, work prioritization, capability building, and clear accountability for product deliverables.
• Analytical LCM Functional & Enterprise Leader working in strong collaboration and communication with the Analytical LCM Portfolio leader, other Analytical LCM Modality leads, MSAT Manufacturing Leads, QC sites and internal and external analytical labs and services to align on ways of working, Dengue vaccine analytical prioritization, network strategy, Dengue vaccine CMC initiatives/roadmaps, and analytical lab work resourcing.
• Tech Forward: Driving towards digital-forward, analytical technology innovation and platforming embedment in analytical methodology.
• Strategic and technical people leader for Dengue vaccine analytical development technical and product strategies, roadmaps & initiatives. Embed risk-based thinking in method development, qualification/validation, and lifecycle management to improve robustness, reduce investigations, and accelerate tech transfer and comparability.

• Single point of accountability for the global Analytical LCM of Dengue vaccine, a live-attenuated tetravalent dengue vaccine (serotypes DENV-1, -2, -3, and -4) manufactured in Vero cells and presented as a lyophilized drug product with diluent for reconstitution.
• Owner of the Dengue vaccine Analytical LCM Strategy across the commercial lifecycle. Deep analytical engagement and understanding of the product control strategy. Works with key stakeholders to create and maintain the analytical plan to meet the overall Dengue vaccine CMC program plan. Oversight of the Dengue vaccine Analytical LCM Roadmap and Method Risk Register and driving communication and proactive planning ensuring appropriate analytical control strategies are in place for the lifetime of the commercial product.
• Strong interface & communication with enterprise leaders in MSAT Analytical, MSAT manufacturing, Pharm Sci, Quality, Regulatory, GSQ, QC sites, and IT to ensure program plans and needs are well integrated and resourced into existing and future control strategies.
• Accountable for the integrated planning for ALL Dengue vaccine-specific analytical LCM activities to ensure continuity of control strategies including methods, regulatory filings, justification of specs, tech transfer, methods remediation planning, process changes, seamless supply and bridging of control strategies for reference standards & key materials, virus seeds and cell banks, analytical change control and comparability strategy owners. Ultimately accountable for Dengue vaccine analytical program-related plans and execution of activities.
• Ensures the Dengue vaccine analytical LCM plans and methods have appropriate quality management across the network, including standards, training, and inspection readiness expectations for data integrity and documentation practices.
• Oversight of the Dengue vaccine method risk register to monitor method performance and proactively implement measures to ensure the product and methods remain in control for the lifetime of use.
• Partner with QA, QC, Manufacturing/MSAT, Regulatory CMC, Supply Chain, and IT to ensure submission-ready analytical sections, inspection readiness, and governance for change control and lifecycle management.
• Contributes to driving analytical technology innovation into the Dengue vaccine analytical LCM program plan in collaboration with MSAT and QC lab network and other key stakeholders that ensures appropriate product control, efficiency, compliance, and quality outcomes.
• Builds and maintains strong enterprise leadership network internally and externally to drive sound technical analytical Dengue vaccine program strategies embedding 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.

• Education: BS/MS in Microbiology, Virology, Immunology, Biochemistry, Biology, or related discipline (PhD preferred).
• Experience: 10+ years in pharma/biotech with depth in Analytical Development and/or QC, with emphasis on leading vaccine analytical programs in development and/or lifecycle management, ideally including live-attenuated viral vaccines. Proficient across vaccine analytical technology applied to drug substance and drug product, especially cell-based potency/infectivity assays, molecular (qPCR/RT-PCR) methods, and immunoassays. Significant people and matrix leadership experience and accountability for strategy, governance, and delivery for a commercial product including BLA/MAA filings and post-approval lifecycle management.
• Control strategy & filings: Demonstrated experience developing analytical control strategies, holistic control strategies and supporting regulatory submissions (IND/IMPD/BLA/NDA/MAA), including specifications/justifications, stability, and comparability strategies.
• 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 key analytical modalities and enabling systems (CDS/LIMS/ELN), including standardization and qualification in regulated environments.
• Analytical development breadth: Understanding of analytical development supporting discovery through manufacturing and regulatory submissions.
• Regulatory support: Experience supporting regulatory submissions and approval processes.
• Scientific leadership & stakeholder management: Strong communication/collaboration; able to manage complex priorities and stakeholders.
• Platform modernization: Track record modernizing analytical platforms or scaling new ways of working.

The salary range displayed reflects the primary location associated with this posting. Compensation may vary for candidates considered in other locations. Where applicable, location-specific salary ranges and compensation information will be provided in accordance with local requirements.

Base Salary Range:

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.

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