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Associate director, tech transfer and external partnerships

Marburg
CSL
Director
Inserat online seit: Veröffentlicht vor 17 Std.
Beschreibung

The Associate Director of Technology Transfer & External Partnerships leads the planning and execution of technology transfer activities to external partners, including CDMOs, CMOs, and strategic collaborators. This role ensures successful transfer of processes, analytical methods, and manufacturing knowledge while maintaining quality, compliance, and timelines. The position also manages external relationships to support development, scale-up, and commercial manufacturing across the product lifecycle.


Main Responsibilities & Accountabilities

Technology Transfer Leadership :

1. Lead end-to-end technology transfer to external manufacturing and development partners
2. Develop and execute tech transfer strategies, plans, and timelines
3. Ensure successful transfer of process, analytical, and quality knowledge
4. Oversee preparation of transfer documentation, risk assessments, and technical packages
5. Monitor execution of engineering, demonstration, and validation batches


External Partner Management :

6. Manage relationships with CDMOs, CMOs, and strategic partners
7. Serve as primary technical and operational contact for external collaborations
8. Evaluate partner technical capabilities, capacity, and compliance status
9. Drive alignment on deliverables, timelines, and performance expectations
10. Support contract scope definition and governance processes


Cross-Functional Coordination :

11. Collaborate with Process Development, MSAT, Manufacturing, Quality, Regulatory, and Supply Chain
12. Ensure readiness for clinical and commercial manufacturing at external sites
13. Coordinate troubleshooting and issue resolution during transfer and production
14. Align internal and external teams on project milestones and risks


Quality & Compliance :

15. Ensure compliance with GMP, regulatory, and quality standards during technology transfer
16. Support deviations, investigations, CAPA, and change control related to external manufacturing
17. Ensure proper documentation and data integrity across partner activities
18. Support audits, inspections, and regulatory submissions


Program & Project Management :

19. Manage multiple technology transfer projects simultaneously
20. Track milestones, risks, budgets, and performance metrics
21. Drive continuous improvement in tech transfer processes and best practices
22. Support lifecycle management and post-transfer optimization


Leadership & Influence :

23. Mentor scientists and engineers involved in tech transfer activities
24. Influence cross-functional and external stakeholders
25. Contribute to strategic planning for external manufacturing and partnerships



Qualifications & Experience Requirements

26. Bachelor’s, Master’s, or PhD in: Chemical / Biochemical / Bioprocess Engineering, Biotechnology, Pharmaceutical Sciences, Chemistry or related technical field
27. 8–12+ years of experience in technology transfer, process development, MSAT, or manufacturing
28. Strong experience working with CDMOs/CMOs and external partners
29. Solid understanding of GMP, regulatory expectations, and quality systems
30. Proven project and stakeholder management experience
31. Strong technical understanding of process scale-up and manufacturing
32. Global technology transfer and external manufacturing networks
33. Process validation and commercial manufacturing support
34. Risk management, QbD, and statistical tools (DoE)
35. Contract governance and vendor performance management
36. Experience supporting regulatory filings and inspections



Key Competencies

37. Technical and operational leadership
38. External stakeholder and partnership management
39. Strategic thinking and execution
40. Strong project and risk management
41. Cross-functional collaboration and influence
42. Quality and compliance mindset
43. Problem solving and decision-makin

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.


CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .

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