Associate Director, Program Management CMC Biologics

Associate Director, Biologics

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit www.abbvie.com.

Purpose:

The Associate Director will be fully accountable for providing CMC leadership to both commercial and development projects with a focus on biologics drug substance. This role serves as a central leader within the Biologics Development and Launch (BDL) group.

Responsibilities:

• Develop comprehensive project plans, budgets, timelines and strategy; biologics projects at all stages of development are included, from phase I through commercial.
• Must present technical information regarding biologics 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 product as well as post-approval life-cycle management.
• Manage multiple projects at various stages of development.
• Represent assigned projects on the multidisciplinary Product Presentation and Device Strategy Team (PPDST) and collaborate with stakeholders including R&D, RA, and Operations (MES, QA, sites, Supply Chain, purchasing, etc.).
• Participate in or lead/coordinate Governance efforts such as Product Performance Teams or gate reviews.

Qualifications:

• Ph.D. in biochemistry, biochemical engineering, cell biology 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 biologics 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 biologics manufacturing process support and/or development, analytical development, or biologics process validation is needed.

Additional Information:

• 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 short-term incentive programs.
• This job is eligible to participate in our long-term incentive programs

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.