Director, ADC CMC Sciences

Responsibilities:
- Lead cross-functional S&T product teams; represent CMC/S&T with S&T leadership, Operations, other AbbVie functions, and external partners; coordinate governance (Product Performance Teams, gate reviews).
- Develop and maintain project plans, budgets, timelines, and strategy for technical projects from Phase II through commercial.
- Ensure proactive CMC technical ownership; drive identification/resolution of technical issues and prioritize efforts with strategic impact to Operations.
- Present technical information on drug product/substance manufacturing processes, process development/history, and process characterization to management and regulatory agencies.
- Review product submissions for registration and post-approval life-cycle management; serve as peer/management reviewer.
- Represent projects on multidisciplinary Product Presentation and Device Strategy Team; collaborate with R&D, RA, Operations (MES, QA, sites, Supply Chain, purchasing, etc.).
- Manage multiple/complex projects across development, commercialization, and commercial manufacturing.
- Develop new/less experienced CMC leads; identify and promote best practices.
- Establish partnerships with key customers and counterparts to enable collaboration.

Qualifications:
- BS with 16+ years (or MS with 14+ years; PhD with 12+ years) in CMC/small molecule manufacturing/development.
- CMC development experience through IND and/or NDA/MAA (leading multiple teams preferred).
- Required: small molecule manufacturing/development, quality, and analytics expertise.
- Required: FDA and global regulatory knowledge for CMC; ability to influence experts independently.
- Strong writing, presentation, communication; excellence leading CMC project teams; ability to provide strategic direction.

Benefits:
- Paid time off; medical/dental/vision insurance; 401(k) (eligible employees).
- Long-term incentive program eligibility.