About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Position will be responsible for CMC leadership and project management for existing and new biologics projects from the drug substance perspective.

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 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 Asset Development Team.

• Ph.D. in biochemistry, biochemical engineering, cell biology or related field with 8+ years of industrial experience (or equivalent) or Master degree in above mentioned field with 16 years of relevant experience, 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.
• Ability to work against tight timeline to meet business goal.
• Experience in biologics manufacturing process support and/or development, analytical development, or biologics process validation is needed.
• 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.

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof thisposting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission,incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless anduntil paid andmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable 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, visithttps://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