New Product Introduction (NPI) Lead

The Company
Our client is passionate about the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden hard-working and multi-scaled people are working in a high-performance culture in which innovation and a 'can do' state of mind are the central points.
 
Role Description
As a NPI Lead, you will be responsible for the coordination and introduction of new products into Quality Control Department.

Responsibilities
– Business case and budget estimations for NPIs requests.
– Project lead for NPI transfers, laboratory NPI capacity increase initiatives, and new technology’s 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.
– Establish and improve standards for content and quality of NPI processes (change controls, method transfers, documentation, communication, etc.) .

 Requirements
– Master/bachelor’s degree in Life Sciences, analytical chemistry, biochemistry, or comparable.
– At least 4 years’ experience in a laboratory/pharmaceutical environment.
– Preferably project management experience.
– Experience with new product introduction.
– Experience in analytical method transfers and/or raw materials qualifications.
– Shown to have excellent safety and GMP awareness and experience
– A quality, compliance, and business minded attitude

Other Information
Are you interested and would like to apply, feel free to contact me.