Director, ADC CMC Sciences at AbbVie — Waltham, MA

Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline small molecule products Plays a key leadership role within S&T PPG group.

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; technical projects at all stages of development are included, 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 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 S&T CMC leads.
• Establish and foster partnerships with key customers and counterpart functions to facilitate effective collaboration.
• 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 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.
• Demonstrated ability to provide strategic direction for work groups, departments, etc.

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.