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Science Talents

Project Management - External Manufacturing Drug Product

Published on Jobat.be 8 days ago

Project Management - External Manufacturing Drug Product

Job description

  • The position holder is responsible to lead cross-functional teams of internal and external persons in the execution of approved technical projects at CMOs such as new product introductions from R&D, technology transfers (including applicable methods transfers) to CMOs, API-related changes, process improvements, process validations, and other-related technical projects.
  • The position holder is able to act as a team leader and project manager, including projects associated of new a process technologies at the CMO.
  • The manufacturing sites that are supported by the person in this position include primarily CMOs in the European region producing AH Small Molecules products.  There may be limited CMOs in the South African regions as well.
  • The position holder will have to travel up to 30% of his/her time.
  • Provide technical oversight, planning, coordination and support to CMOs for projects related to:
  • R&D-to-CMO product transfers
  • Site-to- or CMO-to-CMO product transfers
  • Technical capacity and capability assessment of CMOs
  • API- and excipient-related changes
  • Process-related changes
  • Technical trouble-shooting to support complaints and failures
  • Process Robustness efforts
  • Life cycle management support
  • Process Performance Qualification & Continue Process Verification
  • Overarching changes to products or materials.
  • Support consistent organizational processes and communications
  • Support of direct knowledge transfer between the manufacturing sites, support of development of global key technology platforms, technical expertise and the organisations Division technology network.
  • Facilitation of communication and interface for CMOs to other global departments such as Supply Chain Management, Regulatory Affairs, Commercial Operations/Marketing and Pharma R&D.


Profile

  • Degree in Science (Process technology, Pharmaceutical technology, Industrial Chemistry, Food technology,…)  and at least 5 years of experience in technology or formulation manufacturing/packaging in a Pharmaceutical, or other-regulated company or in extended experience in an academic environment of Pharmaceutical/Chemistry departments.  Sterile formulation experience preferred.
  • Business Experience in projects as technology transfers will be asset.  Business degree a plus.
  • 2 years of experience in high-level project management of technical projects at GMP manufacturing sites
  • Regulatory background incl. EMEA requirements a plus.
  • Strong knowledge of GMP requirements.
  • Language requirements: English (fluent)
  • Spanish or other Eu languages (not required, but helpful)
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    20 days left to apply

    Characteristics

    Requirements

    • Master (University or Higher Education Long Type)
    • English

    Offer

    • Full-time

    Apply before

    • 17 December

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