Project Delegate - Global Process Science Lead DS & DP

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 knowledge 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 know 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

• Knows 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