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Project Delegate - Global Process Science Lead DS & DP

Posted: 06 Jan 2025

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Neuchâtel
English

For our client, an international company based in Neuchâtel, we are looking for a Project Delegate - Global Process Science Lead DS & DP General Information:

  • Workplace: Neuchâtel or Zurich
  • Contract : Temporary
  • Start date : January 2025
  • End date: November 2027
  • Workload: 100%

 Tasks and responsibilities:

  • Project specific Global Process Science Lead representing the Process Owner for a Biologics Large Molecule in the hematology area in a B2B project in South America
  • Represent the Global Process Science Lead in the Technology Transfer project to drive decision making at local/site level from a Global perspective to establish site readiness for Engineering and PPQ runs
  • Represent kledge from Sending Unit (Process and Manufacturing)
  • Connect with Site Project team and External Business Partner Team (which is owning the receiving Unit) to explain criticality of process steps, share Manufacturing k how and serve as a Senior Technology consultant
  • Firm in understanding of best practices and regulation to perform Process Performance Qualification for a commercialized product in South America
  • Drive Technology transfer (TT) document creation as per methodology
  • Establish and maintain effective communication channels with stakeholders, providing regular updates on process transfer risks, status, and mitigation recommendations. 
  • Develops gap assessments and mitigation recommendations together with Process Science Leads and subject matter experts, seeks stakeholder and leadership endorsement
  • Review documents and provide risk assessments and rationales to support the different phases of a TT, including PQ,PPQ and manufacturing activities

 Your profile:

  • Min. MSc in Biotechnology or comparable education
  • Fluently English skills
  • Fluently French or Portuguese skills would be beneficial
  • Well established DS (Cell Culture and Purification) and DP (Filling, Lyo) expertise
  • Has/shows seniority/maturity on technical level and when interacting with teams and SMEs
  • Can work autonomously
  • Consultancy/contractor experience
  • Ks how to work in a team/matrix environment (work consensual and data driven, avoids directive communication)
  • Can navigate in complex environments (Internal Global/Local model & (business) partnerships)
  • PPQ/TT experience
  • Open to Travel internationally