GMP Specialist - USP

Location Leiden, Gemeente Leiden, South Holland
Discipline: Other, Biotechnology, Pharmaceutical
Job type: Temporary/Freelance
Contact name: Gemma Dozy

Contact email:
Job ref: 13514
Published: about 2 months ago

At the moment I am looking for a GMP Specialist with a focus on USP for one of my biotech clients in Leiden. This is a lead position for the NPI team and a long term role.

The NPI Team is responsible for the tech transfer and production.


  • Your duties as a New Product Introduction Process Specialist:
  • You ensure that the NPI is correctly introduced to Operations.
  • You implement improvements within your department and area of ??responsibility.
  • You support and supervise all activities related to production and export of new products (NPI), processes and technologies
  • You create and train (Sr) Operators in the shift for new processes and technologies
  • You support and give advice in translating new processes from day shift specialists to the workplace (matters such as smooth workflow, ergonomics, safety, efficiency, practical feasibility).
  • You write, adapt and review instructions / procedures / work instructions related to new processes, products (NPI)



  • Biologics Upstream Processing experience (very important)
  • MBO +4 years experience or HBO/WO with +2 years
  • Experience with the route cause problem solving
  • Project Management experience
  • Experience with the Environmental, Health, Safety & Sustainability or Good Manufacturing Practice standards (GMP)
  • You are a strong communicator and a bridge builder
  • You like to work together in a team (easily approachable and approach yourself easily at various levels)
  • You can set up training courses and transfer knowledge (as a qualified trainer)
  • You are enthusiastic, independent, innovative (you can think out of the box) and resistant to stress (can deal with pressure, rapid changes)
Project start date
  • August or September preferred
Project duration
  • 1 year

If you’re interested in the above description, please apply with your CV and a letter of motivation by clicking on the ‘apply’ button below.

PS: Did you also know that we offer a generous referral scheme, because great people know other great people, right?

For further information, please contact Gemma Dozy at +31 (0)20 20 44 502 or by email at