Director, ADC CMC Sciences

About the role

Full-time, dedicated responsibility for CMC (Chemistry, Manufacturing, and Controls) leadership and project management for commercial and pipeline small molecule products. Plays a key leadership role within the Science & Technology (S&T) Product Portfolio Group (PPG).

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 and maintain comprehensive project plans, budgets, timelines, and strategy for technical projects at all stages of development, from phase II through commercial.
• 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 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 management and regulatory agencies.
• Review submissions through registration of the product as well as post-approval life-cycle management. Serve as a peer/management reviewer for submissions.
• Represent assigned projects on the multidisciplinary Product Presentation and Device Strategy Team and collaborate with multidisciplinary teams including R&D, Regulatory Affairs (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 S&T CMC leads.
• Establish and foster partnerships with key customers and counterpart functions to facilitate effective collaboration.

Qualifications

• Bachelor’s Degree with 16+ years of relevant experience (CMC, small molecule manufacturing/development); Master’s Degree with 14+ years of relevant experience; PhD Degree with at least 12+ years of relevant experience.
• CMC development experience through IND (Investigational New Drug) and/or NDA/MAA (New Drug Application/Marketing Authorization Application). 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.
• Demonstrated ability to provide strategic direction for work groups, departments, etc.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in long-term incentive programs.