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  • Location

    Leiden, Gemeente Leiden, South Holland

  • Job title:

    NPI Process Specialist

  • Sector:

  • Job ref:

    46371

  • Start Date:

    2021-06-24

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 NPI Process Specialist you will be responsible for the tech transfer of new product manufacturing processes into the main production plant. 

Responsibilities 
- Ensure that the NPI is correctly introduced to Operations, including equipment and methodology 
- Implement process improvements in your area of responsibility 
- Support and supervise all activities related to production and export of new products (NPI), processes and technologies
- Train (Sr) Operators for new processes and technologies
- Write, adapt and review instructions / procedures / work instructions related to new processes, products (NPI)
- GMP documentation; change controls, deviations, CAPAs, materials qualification, root cause analysis


Requirements 
- Min. bachelor's degree in a Life Sciences discipline 
- Experience in manufacturing of biologic products, preferably multiple products/processes
- Experience in a GMP environment and knowledge of Quality systems 
- Experience with tech transfer is a big plus 
- Experience with New Product Introduction is a big plus 
- Excellent communication skills in English, Dutch is appreciated


Other Information 
For more information please contact Carla Garcia at c.garcia@sire-search.com or +31 (0) 20 658 98 01. 
 

Contact us

SIRE® LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE® STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
The Netherlands
+31 (0) 20 658 9804