Project Delegate

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