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