Experis, the global leader in professional resourcing and project-based workforce solutions, is seeking a highly skilled Project Delegate - Global Process Science Lead DS & DP for our client in Basel.
This 3-year role requires strong technical expertise and excellent interpersonal skills to represent the Process Owner for a Biologics Large Molecule in a B2B project in South America.
Primary Duties:
* Represent the TAK Global Process Science Lead in Technology Transfer projects, driving decision making at local/site level from a Global TAK perspective to establish site readiness for Engineering and PPQ runs.
* Connect with TAK Site Project teams and External Business Partner Teams to explain critical process steps, share manufacturing knowledge, and serve as a Senior Technology consultant.
* Develop a firm understanding of best practices and regulations to perform PPQ for commercialized products in South America.
* Establish and maintain effective communication channels with stakeholders, providing regular updates on process transfer risks, status, and mitigation recommendations.
Responsibilities:
1. Collaborate with cross-functional teams to develop gap assessments and mitigation recommendations.
2. Review documents and provide risk assessments and rationales to support TT phases, including PQ, PPQ, and manufacturing activities.
3. Ensure compliance with regulatory requirements and industry standards.
Key Skills:
* Demonstrate senior-level technical expertise and effective communication skills when interacting with teams and subject matter experts.
* Proven consultancy/contractor experience.
* Able to navigate complex environments and work collaboratively in matrix structures.
* PPQ/TT experience and knowledge of industry regulations.
Requirements:
* Open to travel to Brazil.
* Fluent in English; fluency in French or Portuguese is beneficial.