Leiden, Gemeente Leiden, South Holland
NPI Process Specialist
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 Process Specialist you will be responsible for the tech transfer of new product manufacturing processes into the main production plant.
- 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
- 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
For more information please contact Carla Garcia at firstname.lastname@example.org or +31 (0) 20 658 98 01.