NPI Lead (Quality Control)
Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of monoclonal antibodies to protect people worldwide from immunological diseases.
As a NPI Lead you will be responsible for the introduction of new products in the Quality Control laboratory.
- Point Of Contact (SPOC) for all NPI activities, from Phase 1 to Late Stage NPIs throughout the CMC stage gates
- Business case and budget estimations for NPIs requests
- Project lead for NPI transfers, laboratory NPI capacity increase initiatives, and new technologies introduction
- Ensure NPI testing plan is aligned with the platform testing strategy
- Support the testing teams aligning NPI volumes with testing capacity
- Coordinating the analytical method transfer end-to-end
- Raw materials qualification
- Partner with local and global stakeholders
- Alignment of NPI global teams and department testing teams needs and requirements to ensure flawless and on-time NPI introduction
- Laboratory testing readiness
- Ensure new products introduced have required robustness and reliability of a commercial lab
- Establish and improve standards for content and quality of NPI processes (change controls, method transfers, documentation, communication, etc.)
- Master/Bachelor degree in Life Sciences, analytical chemistry, bio chemistry, or comparable
- 4 years of experience in a GMP environment in QC or analytical development with large molecules
- Project Management experience
- Experience with New Product Introduction (NPI)
- Experience in analytical method transfers and/or raw materials qualifications
- Excellent communications skills in English
For more information please contact Ece Karakurt at email@example.com or +31 (0) 20 658 98 01.