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  • Location

    Leiden

  • Job title:

    NPI Lead (Quality Control)

  • Sector:

  • Job ref:

    47002

  • Start Date:

    2021-12-01

The Company 
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.

Role Description 
As a QC NPI Lead you will be responsible for the introduction of new products in the Quality Control lab, for products manufactured in various locations. 

Responsibilities 
- Point of Contact for NPI activities from Phase 1 to Late Stage NPI throughout the CMC stage gates 
- Business case and budget estimations for NPI requests 
- Project lead for NPI transfers, laboratory NPI capacity increase and new technologies introduction 
- Coordinate analytical method transfer end-to-end 
- Raw materials qualification 
- Laboratory testing readiness 
- Establish and improve standards for content and quality of NPI processes 


Requirements 
- BSc/MSc in Life Sciences, Analytical Chemistry, Biochemistry or similar 
- 4+ years of experience in a laboratory/pharmaceutical environment 
- Experience with analytical method transfer 
- Experience with new product introduction 
- Experience with a wide range of large molecule analytical methods 
- GMP experience 
- Preferably project management experience 
- Excellent communication skills in English 


Other Information 
Initial contract for 6 months, extension anticipated. 
For more information please contact Ece Karakurt  at e.karakurt@sire-search.com or +31 (0) 20 658 98 01