Global Process Science Lead DS & DP

• 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 TAK Global Process Science Lead in the Technology Transfer project to drive decision making at local/site level from a Global TAK perspective to establish site readiness for Engineering and PPQ runs
• Represent knowledge from Sending Unit (Process and Manufacturing)

• Connect with TAK Site Project team and External Business Partner Team (which is owning the receiving Unit) to explain criticality of process steps, share Mfg know how and serve as a Senior Technology consultant
• Firm in understanding of best practices and regulation to oerform PPQ for a commercialized product in South America
• Drive TT document creation as per TAK 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.

• Min. MSc in Biotechnology or comparable education
• 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 autonomous
• 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 to Brazil
• Fluently English skills
• Fluently French or Portuguese skills would be beneficial

Experis