Position will be responsible for CMC leadership and project management for existing and new biologics projects from the drug substance perspective.

Responsibilities:

• Lead cross-functional S&T product teams and represent the CMC team and/or S&T in interface with S&T leadership, other Operations functions, other AbbVie functions and external partners. Participate in or coordinate Governance efforts such as Product Performance Teams or gate reviews.
• Develop comprehensive project plans, budgets, timelines and strategy; biologics projects at all stages of development are included, from phase I through commercial.
• Must present technical information regarding biologics manufacturing, process development and process characterization to management and to regulatory agencies.
• Prepare and review regulatory briefings and submissions to support clinical trials through registration of the product as well as post-approval life-cycle management.
• Manage multiple projects at various stages of development.
• Represent assigned projects on the multidisciplinary Asset Development Team.