Abbvie Product Development Science and Technology (PDS&T) Biologics Analytical-CMC Strategy is responsible for driving the analytical CMC control strategy for late-stage development of biologics. The Analytical CMC Strategy team is responsible for ensuring late phase to commercial method development, optimization, validation, advanced characterization, process development support, regulatory authoring, and control strategy for biologics. The team works cross-functionally with process development, regulatory, and quality within the Abbvie network. This role requires a strategic thinker with a strong technical analytical background in gene therapy and tLNP technologies, manage complex projects, and effectively communicate cross-functionally.            

Responsibilities

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• Drives overall analytical control strategy, including justifying appropriate specifications, determining critical quality attributes, assessing product shelf-life, and risk-based comparability strategies for the biologics pipeline.
• Establish collaborations across the organization to ensure delivery of critical analytical BLA enabling activities.
• Setting team strategies, managing resources and defining risk mitigation strategies.
• Communicate project strategy, key issues, and risks to relevant teams and escalate risks and facilitate resolution within/across functional areas.
• Act as the principal contact for all stakeholders and balance conflicting expectations between cross-functional areas.
• Actively participate in yearly FTE planning across the analytical organization