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(Associate) Director, Analytical Sciences (Biophysical, Particulates)

Company: IMVT Corporation
Location: New York
Posted on: September 25, 2022

Job Description:

Organizational Overview:
Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.
The Role:
The (Associate) Director, Analytical Sciences will be responsible for analytical activities in support of the development, manufacturing, and commercialization of Immunovant's biotherapeutic assets, with focus on biophysical techniques and methods for particulate analysis as part of characterization and comparability studies. In addition, the incumbent will be expected to provide support for method development, qualification/validation, and transfer activities, as well as crafting technical documents and relevant sections of regulatory filings. The successful candidate should be knowledgeable in various techniques associated with analysis secondary, tertiary, and higher order structures of biological products, as well as thermal stability and particulate analysis and the underpinning theory behind each technique. This role will require significant external vendor oversight with review of primary raw data as well as contributing to key processes such as critical quality attribute assessment, development of specifications, and design of comparability and characterization studies.
Key Responsibilities:


  • Provide analytical oversight of characterization testing via biophysical and particulate analyses
  • Analyze, interpret, and collate raw data from external testing laboratories; craft detailed technical documentation to capture and summarize testing outcomes
  • Design comparability studies with justification of acceptance criteria
  • Establish current and long-range plans and objectives required to assure data availability and appropriate documentation in preparation for regulatory filings
  • Ensure external testing laboratories execute qualification of characterization methods to regulatory expectations
  • Monitor and assess emerging literature and regulatory expectations to determine impact to Immunovant and works to remediate any identified gaps
  • Support laboratory investigations for routine manufacturing and development activities where appropriate
  • Author and review technical documents and relevant sections of Immunovant global regulatory submissions

    Requirements:

    • PhD or equivalent in Biology/Chemistry/Engineering/Pharmaceutics or another relevant field with 2+ years. BS or MS with correspondingly longer experience will be considered
    • Experience in managing analytical projects with contract testing labs and/or CDMOs
    • Expertise in analytical techniques used to assess protein secondary, tertiary, and higher order structure, thermal stability, and techniques for evaluating particulates in high concentration protein formulations
    • Experience with, and a good understanding of, FDA and other regulatory agency regulations and guidances including ICH documents is required
    • Knowledge of cGMP regulations, ICH guidelines, and world-wide health authority requirements
    • Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results
    • Demonstrated communication, problem-solving, leadership, and negotiation/decision-making skills
    • Ability to think outside of the box and challenge the status quo
    • Desire to work in a fast-paced, innovative environment
    • Natural collaborator who enjoys working on a cross-functional team.

      Work Environment:

      • Remote-based; will have access to Immunovant's NYC/NC offices
      • Dynamic, interactive, fast-paced, and entrepreneurial environment
      • May require up to 10% travel

Keywords: IMVT Corporation, New York , (Associate) Director, Analytical Sciences (Biophysical, Particulates), Executive , New York, New York

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