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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.

VP, Small Molecule Analytical R&D

Primary Lake County, Illinois Req ID 2212405 Category Research and Development Division AbbVie

Purpose:

Describe the primary goals, objectives or functions or outputs of this position.

Leads the Global Small Molecule Analytical R&D function within Small Molecule CMC Development, AbbVie R&D Development Sciences. Develops and implements effective strategies for global small molecule analytical research and development to support CMC activities required for clinical development, regulatory submissions, approval and initial launch of AbbVie products. Recognized industry leader who drives scientific excellence, with expertise in CMC development, regulatory and quality compliance, and adept at developing intellectual property positions. Works across multiple functional areas to deploy capabilities for advancing AbbVie’s pipeline. Balances capability and capacity of technical expertise across multiple groups ensuring effective decision making in a timely and expeditious manner. Creates an environment to attract, develop, retain and promote excellent diverse scientific talent, communicates clearly and concisely and builds effective relationships with internal and external partners and customers.        

Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

  • Lead Small Molecule Analytical R&D, a major function within the R&D CMC organization with complete accountability for AbbVie’s small molecule R&D pipeline
  • Ensure that the function provides scientific leadership and analytical excellence to drive the development and commercialization of robust and cost-effective small molecule drug substance and drug product manufacturing processes and products.
  • Ensure scientific expertise and direction is provided to business strategy and decision making processes. Makes difficult scientific decisions to meet changing business needs. Fosters collaborations with other functions within and outside the R&D organization.
  • Ensure development of strategies that drive stage appropriate analytical development, operational excellence and scientific innovation to improve the future capabilities and productivity of the greater organization
  • Responsible for talent strategy, including leadership and technical development within the function to generate future senior scientific talent and leaders. This includes establishing a sustainable high functioning team that seamlessly integrates with the Product Presentation & Device Strategy Teams (PPDST) and Asset Strategy Teams (AST). Fosters and encourages a truly collaborative organization with high morale and consistent with expectations set by AbbVie’s Talent Philosophy.
  • Collaborate with other functions within AbbVie to align on a broad range of strategies that directly support small molecule drug discovery and development programs; these include but are not limited to other areas in Development Sciences, Discovery Research, Small Molecule Drug Substance Development, Small Molecule Drug Product Development, Regulatory Affairs, Quality Assurance and Commercial Manufacturing Operations.
  • Form particularly strong cross-functional alliances with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs and Commercial Manufacturing Operations to ensure robust and effective control strategies in development and commercialization of APIs and drug products by driving innovation and consistency in analytical development practices.
  • Responsible for critical path decisions, strategic planning and technology development to meet business and regulatory requirements
  • Accountable for small molecule analytical development and test method transfer to commercial plants and commercial quality control laboratories.
  • Responsible for compliance with applicable Corporate policies and procedures.
  • Has full annual budgetary control/discretion within approved annual budget.

 


Qualifications:

List required and preferred qualifications (up to 10). Include education, skills and experience.

  • PhD in chemistry, analytical chemistry, chemical engineering or closely related discipline with 10+ years of experience in pharmaceutical and/or biotechnology industry.
  • Senior leadership experience leading large and highly technical organizations.
  • Expertise in small molecule analytical development and CMC development, and some experience in biologics analytical development. Broad understanding of both scientific and regulatory requirements in the areas of responsibility and overall pharmaceutical R&D, as well as manufacturing and quality.
  • Demonstrated ability and dynamic leadership capabilities to operate highly effectively in a cross functional matrixed environment.
  • Demonstrated ability to attract and develop strong talent, grow the capabilities of an organization and develop people into future leaders.
  • Proven capability to solve critical business and scientific problems.
  • Demonstrated experience in budgetary, talent and performance management responsibilities.
  • Experience leading in a global environment.
  • Recognized CMC leader in the pharmaceutical and biotechnology industry. 
  • Strong understanding of cGMP and global regulatory requirements.

Significant Work Activities: N/A
Travel: Yes, 15 % of the Time
Job Type: Experienced
Schedule: Full-time
ABBVIE

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