CMC-Pharma Product Group Associate Director

Role Summary

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.

Responsibilities

• 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 Chain, purchasing, etc.)
• Manage multiple and/or complex projects at various stages of development, commercialization and commercial manufacturing.
• Develop new and less experienced CMC leads through sponsor/mentor relationships.
• Identify and promote best practices among PDS&T CMC leads.
• Establish and foster partnerships with key customers and counterpart functions to facilitate effective collaboration.

Qualifications

• Bachelor’s Degree with 14+ years of relevant experience (CMC, small molecule manufacturing/development); Master’s Degree with 12+ years of relevant experience; PhD Degree with at least 10+ years of relevant experience.
• CMC development experience through IND and/or NDA/MAA. Experience leading multiple CMC project teams through IND and NDA/MAA preferred.
• Technical understanding and experience with small molecule products manufacturing, development, quality and analytics is required.
• Knowledge and experience with FDA and global regulatory requirements for CMC issues is required. Ability to influence internal and external experts on CMC regulatory issues, independently.
• Demonstrated excellence in writing, presentation, and overall communication.
• Demonstrated excellence in leading CMC project teams.

Skills

• Strong project management and cross-functional leadership
• Regulatory strategy and submission preparation
• Technical writing and effective communication
• Collaboration with R&D, RA, Operations, QA, and Supply Chain