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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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Associate Director, Analytical CMC Lead

Worcester, Massachusetts Req ID 2207480 Category Regulatory Affairs Division AbbVie

AbbVie is searching for a highly motivated individual to fill an Associate Director, Analytical CMC lead role in the Analytical Development Department at AbbVie Bioresearch Center in Worcester, MA. The Analytical Development Department is responsible for analytical method development, method qualification and transfer to QC, and execution of analytical methods to provide product and process understanding, as well as analytical CMC program management for AbbVie biopharmaceutical pipeline from discovery through commercial stages.

As an Associate Director, Analytical CMC Lead, you will join the Analytical Development team within the Science and Technology organization and embrace the opportunity to transform amazing sciences and technologies into powerful therapeutics. As a senior member of the Analytical Development department, you will also represent Analytical Development on cross-functional early and late-stage biologics program CMC development teams and be responsible for communicating and executing the analytical strategy for AbbVie's biological assets.

Key Responsibilities:

  • Represent Analytical Development within the CMC teams across AbbVie for both early-stage and late-stage assets
  • Work cross-functionally and collaboratively to meet company milestones and drive Analytical Development deliverables
  • Establish and communicate analytical program goals and ensure operational plans are in place to execute the analytical strategy
  • Support the risk assessment and documentation of CQAs for the late-stage product
  • Identify and implement improvement in analytical development strategies in Analytical Development and influence cross-functionally with other analytical organizations in AbbVie
  • Author / review Module 3 contents for the early- and late-stage program(s) as needed
  • Streamline and harmonize workflows within Analytical Development and cross-functionally to drive speed and efficiency in AD CMC program management
  • Be the AD CMC SME and train new analytical CMC leads in Analytical Development
  • BS, MS or PhD degree in chemistry, biology, biochemistry, or related technical discipline with 18+ (BS), 12+ (MS) or 7+(PhD) years of relevant experience in academic or biotech/pharmaceutical industry setting or equivalent
  • Minimum of 7 years of biopharmaceutical analytical experience with recombinant biologic modalities and exposure to various stages of biologics drug development
  • Hands-on working experience in IND, IMPD, BLA/MAA authoring, review, submission, and regulatory response
  • Strong knowledge of CMC analytical and regulatory requirements
  • Must be a good technical writer with experience writing technical documents including comparability protocols/reports
  • Must have an in-depth understanding of analytical comparability studies
  • Knowledge of industry USP/ICH guidance for the development, qualification/ validation of analytical methods
  • Ability to work effectively cross-functionally in anticipating and responding to overall program development needs
  • Demonstrated record of independent thought, creativity and scientific accomplishment
  • Self-motivated with the ability to act with urgency and passion
  • Ability to make thoughtful, integrated, timely and meaningful recommendations and/or decision and take corresponding actions
  • Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strengthen decision-making
  • Resourceful, enthusiastic and results-oriented

Key Leadership Competencies:

  • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance
  • Delivers business results while also positioning AbbVie for long-term success
  • Raises the bar and is never satisfied with the status quo
  • Creates a learning environment, open to suggestions and experimentation for improvement
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality
Significant Work Activities: N/A
Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time

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