- Where
- Zurich, Switzerland · USA - MA - Lexington · AUT - Linz - St. Peter Strasse 25 · BEL - Lessines · DEU - Singen
- Level
- Senior
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Job Description
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.
About the role:
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.
How you will contribute:
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…