Associate Director, Program Management CMC Biologics

Company Description

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 us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

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

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• 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​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

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. 

• US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
• https://www.abbvie.com/join-us/reasonable-accommodations.html