About AbbVie AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Description: Clinical Supply Management (CSM) is a part of the Clinical Drug Supply Management (CDSM) organization within R&D Development Sciences. CSM is responsible for the management, planning, packaging, labeling, and distribution of investigational products and clinical trial materials to support all AbbVie Phase I to Phase IV studies, along with Investigator Initiated Studies and Compassionate Use situations. Forecasting, planning, scheduling, coordination and execution, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots. Associate Director Purpose: Responsible for CMC leadership and project management for existing and new small molecule projects. Responsibilities: •Develop comprehensive project plans, budgets, timelines and strategy; technical projects at all stages of development are included, from phase II through commercial. •Must resent technical information regarding Drug product and Drug Substance manufacturing, process development and process characterization to management and to regulatory agencies. •Prepare and review regulatory briefings and submissions to support clinical trials through registration of the products as well as post-approval life-cycle management. •Manage multiple projects at various stages of development, commercial and commercial manufacturing. •Represent assigned projects on the multidisciplinary Asset Development Team. Qualifications Basic: •Education: Bachelor’s Degree required preferably in physical science, math, engineering or pharmacy; or related field with 8+ years of industrial experience (or equivalent) is required. •Very strong writing, presentation and communications skills are required. •Significant technical understanding of Drug Product and Drug Substance manufacturing as well as associated quality and analytical issues is required. •Ability to work in a highly matrixed team and to influence scientists and SMEs in other disciplines is required. •Experience in manufacturing process support and/or development, analytical development, or process validation is needed. Key Leadership Competencies: Builds strong relationships with peers and cross functionally with partners outside of the immediate team to enable higher performance Learns fast, grasps the “essence” and can change course quickly where indicated Raises the bar and is never satisfied with the status quo Creates a learning environment, open to suggestions and experiments to drive the science in the field of interest Embraces the ideas of others, nurtures innovation and manages innovation to reality Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code M Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.