CMC-Pharma Product Group Associate Director

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Pharma Product Group Associate Director will be fully accountable for providing CMC leadership and managing projects related to both commercial and pipeline small molecule products. This role serves as a central leader within the S&T PPG group.

• Independently lead complex cross-functional PDS&T product teams. Represent the CMC team and/or PDS&T in interface with PDS&T leadership, other Operations functions, other AbbVie functions and external partners.  Participate in or lead/coordinate Governance efforts such as Product Performance Teams or gate reviews.
• Develop and maintain comprehensive project plans, budgets, timelines and strategy; technical projects at all stages of development are included, from phase II through commercial. Develops and executes the control strategy for Pipeline products with limited oversight/support.
• Ensure sound, proactive technical ownership of the product, process and methods by the CMC team; facilitate the identification and resolution of technical issues and prioritization of efforts with strategic understanding of the impact on Operations.
• Understand and present technical information regarding drug product and drug substance manufacturing processes and methods, process development/history and process characterization to senior management and regulatory agencies.
• Prepare and review submissions through registration of the product as well as post-approval life-cycle management. Serve as a peer reviewer for regulatory submissions.
• Represent assigned projects on the multidisciplinary Product Presentation and Device Strategy Team and collaborate with multidisciplinary team including R&D, RA, and Operations (MES, QA, sites, Supply Cha