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(senior) Manufacturing Fill & Finish Process specialist

Vacaturenummer: A2000172
Janssen Vaccines & Prevention - Leiden (Nederland)

For our client, Janssen Vaccines & Prevention, we are looking for a (senior) Manufacturing Fill & Finish Process specialist.

The Fill & Finish Process (FFP) team is responsible for the external manufacturing of drug product. As manufacturing FFP specialist, you will operate at the technical interface between the Janssen project team and the external drug product manufacturing sites and your main responsibilities will be:

  • Proper and timely execution of drug product manufacturing activities;
  • Review of the (master and executed) batch documentation prepared by the manufacturing site and bringing it to the required quality level;
  • Being physically present during drug product manufacturing (Person in Plant, PiP), resolving issues on the spot and guiding corrective measures if required;
  • Establishing and maintaining a trustful and professional relationship with the external drug product manufacturing sites;
  • Participating in the multidisciplinary project teams, ensuring alignment with project needs;
  • Identifying and implementing improvements in the way of working;
  • Being all-round expert in quality, regulatory, technical and business aspects of external manufacturing.

Who we're looking for
The ideal candidate has an M.Sc. or B.Sc. in pharmaceutical sciences (or i.e., pharmacy, (bio)chemistry) with at least 5 years of experience (10 years for the senior position) in vaccine and/or large molecule GMP drug product manufacturing. We are looking for someone with experience in GMP and Fill Finish processing. Experience with process development, project management and out sourcing is highly advantageous.
Their highly dynamic environment requires you to have a strong work ethic, expect change and be creative. We are, therefore, looking for someone who is pro-active, flexible and full of initiative. This position may require travelling and staying abroad for up to 1 week and work independently on location (when allowed).

Company profile
Janssen Vaccines & Prevention is dedicated to bringing meaningful innovation to global health. They focus on the discovery, development, manufacturing and marketing of vaccines and antibodies to protect people world-wide from infectious diseases.

Additional vacancy information
Contract:Temporary contract with CLS Services
Education:WO/MSc. HBO/BSc.
Employment terms:Project for at least 1 year.
Publication date:23-11-2020
Location:View location with Google Maps
Contactperson:Claudia Erwich-Faaij
+31 (0)88 22 77 555

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.