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)
- August or September preferred
- 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 firstname.lastname@example.org