Experis is the global leader in professional resourcing and project-based workforce solutions.
On behalf of our Pharmaceutical company in Basel, we are looking for a Project Delegate - Global Process Science Lead DS & DP
Duration: approximately 3 years
Primary Duties:
• 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).
Responsibilities:
1. 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.
2. Firm understanding of best practices and regulations to perform PPQ for a commercialized product in South America.
3. Drive TT document creation as per TAK methodology.
4. Establish and maintain effective communication channels with stakeholders, providing regular updates on process transfer risks, status, and mitigation recommendations.
5. Develop gap assessments and mitigation recommendations together with Process Science Leads and subject matter experts, seeking stakeholder and leadership endorsement.
6. Review documents and provide risk assessments and rationales to support the different phases of a TT, including PQ, PPQ, and manufacturing activities.
Key Skills:
1. Shows seniority/maturity on a technical level and when interacting with teams and SMEs.
2. Consultancy/contractor experience.
3. Knows how to work in a team/matrix environment (work consensual and data-driven, avoids directive communication).
4. Can navigate in complex environments (Internal Global/Local model & (business) partnerships).
5. PPQ/TT experience.
Other Requirements:
1. Open to travel to Brazil.
2. Fluent in English.
3. Fluency in French or Portuguese would be beneficial.
If this job interests you, please send us your CV today through the link in the advert. However, should you have any questions, please contact Elaine Kanwar at elaine.kanwar(at)experis.ch or at +41 61 282 22 23.
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