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Group Leader, Analytical Characterization

Company: AbbVie
Location: Worcester
Posted on: July 13, 2019

Job Description:

The Protein Analytics Department is searching for an innovated and motivated Group Leader to lead the Analytical Characterization Group at the AbbVie Bioresearch Center in Worcester, MA. Our department is responsible for analytical method development, method execution, qualification, and transfer to Quality Control. We also build product and process knowledge, as well as analytical CMC program management in support of the development and registration of AbbVie's biologic pipeline of preclinical, clinical and commercial products.As a Group Leader, you will be a highly experienced, and influential scientist who will lead 6 Senior Scientists in accomplishing detailed protein structure characterization using advanced analytical technologies such as but not limited to mass spectrometry and biophysical methods. You will assist in defining and executing overall biologics analytical development strategy. As a key member of the management team, you will interact effectively and transparently with team members and cross-function group leaders in the areas of Protein Analytics, Process Sciences, Manufacturing Sciences, Quality Control, Quality Assurance and CMC Project Management. Key Responsibilities Include:

  • Lead and handle analytical characterization group activities by working with a group of senior scientists to ensure efficient day-to-day group operation; high-quality data generation and interpretation to drive the growing product and process understanding required as part of biologic portfolio development
  • Drive identification, evaluation and implementation of new technologies
  • Collaborate cross-department; define and execute the most effective approach to meet the demands of biologic development
  • Represent analytical function in the CMC program team and lead analytical CMC program management within the group;
  • Own the development of overall analytical control strategy for biologic programs
  • Author and review filing documents and regulatory responses
  • Contribute to the operation strategy development in Protein Analytics; foster close collaboration within the department and across functions for effective execution of department goals
  • Develop a culture of continuous learning and growth in the group and create development opportunities for members of the group
    • Bachelors, Masters or PhD degree in chemistry, biology, biochemistry or related technical discipline with typically 16+ (BS), 14+ (MS), or 8+ (PhD) years of relevant experience in biotech/pharmaceutical industry setting or equivalent
    • Minimum of 8 years of biopharmaceutical analytical development experience with diversity of recombinant biologic modalities and exposure to all stages of biologics drug development is preferred
    • Extensive hands-on experience with mass spectrometry, chromatography, electrophoresis and other analytical techniques
    • Hands-on working experience in IND, IMPD, BLA/MAA authoring, review, submission, and regulatory response
    • Strong knowledge of CMC analytical and standards, such as CQA assessment, analytical control strategy, and specification setting
    • Proven track record of leading protein analytical characterization and enabling problem-solving in sophisticated situations or for complex modalities
    • Ability to work effectively cross-functionally in anticipating and responding to overall program development needs
    • Demonstrated record of independent thought, creativity and scientific accomplishment
    • Ambitious 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
    • Inventive, hardworking and results-oriented
    • Previous people managerial experience is desired

Keywords: AbbVie, Worcester , Group Leader, Analytical Characterization, Other , Worcester, Massachusetts

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