Job Properties
  • Job Type
    Full-time Position
  • Background
    Biotech and Agricultural
    Management & Business Others
    Medical and Healthcare
    Other Science and Tech
  • Category
  • Languages
    English
  • Experience Required
    10+ Years
  • Degree Required
    Bachelor
    • Province
      5,423 reviews
    • Date Posted
      May 13,2021
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    Senior Director, Analytical Development Europe

    Janssen Research and Development, LLC is recruiting for a Senior Director, Analytical Development Europe to be based in the Netherlands, Ireland, or Switzerland.

    Janssen Research and Development, LLC develops treatments that improve the health and lifestyle of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders and reproductive medicine.

    The Analytical Development group is seeking a Senior Director to lead the Europe Analytical Development organization that is responsible for supporting large molecule commercial products globally and providing support for large molecules in development within the Biotherapeutic’s Analytical Development organization in the EU.

    Primary Responsibilities:

    • Establishes and drives implementation of short and long-term Analytical strategies and execution across multiple teams in Ireland, Netherlands, and Switzerland with direct and indirect reports consisting of ~150 scientists and ~100 contractors.
    • Support life cycle management of all commercial products globally as well as support all large molecules in development. Activities includes clinical release and stability, device development, method development, validation, & transfers, and commercial investigations.
    • Identifies and develops innovative solutions for product development, for complex scientific and technical issues, and investigations
    • Collaborate cross-functionally within R&D, and with stakeholders in supply chain, Quality and Regulatory
    • Accountable for preparing and delivering Analytical sections for rest of world filings of BLA, and post approval supplement, and participate in meetings with health authorities and inspectors. The individual is also responsible for some of the Analytical sections for IND and BLA.
    • Influences peers, stakeholders, and senior leaders on strategies and operational execution to achieve business objectives
    • Assists with developing and implementing talent strategies, and coaches and mentors’ staff on their projects and their careers.
    • Communicates overall program strategies and key milestones to peers and senior leaders
    • Manages and balances resource allocation across a large group of critical projects and drives operational efficiency to reduce cost and time for Analytical Development


    Qualifications
    • Ph.D. in Biochemistry, Biology, Immunology, Biological Chemistry, or related discipline.
    • At least 12 years of technical and leadership experience in biopharmaceutical industry including 3-5 years of experience performing progressively advanced duties at the Director level in Analytical Development.
    • Proven track record of directly leading leaders and managers of managers across different functions
    • Primary in-depth experience in protein pharmaceutical development is needed including large molecule analytics and proven experience in IND and BLA authoring for large molecules
    • Experience in multiple analytical technologies required for process and product development
    • Experience in method development, validation and transfers to meet ICH guidelines.
    • Excellent oral and written communication skills is a must
    • Excellent interpersonal skills with the ability to adapt effectively to manage a growing portfolio

    Primary Location
    Netherlands-South Holland-Leiden-
    Other Locations
    Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-Ireland
    Organization
    Janssen Biologics (7266)
    Job Function
    R&D
    Requisition ID
    2105929388W
     
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