Process Validation Manager

Omschrijving

Are you in for a long term project and are you an experienced Process Validation or Chemistry Manufacturing Control Manager? At Bilthoven Biologicals we are committed to produce as many polio vaccines as we can to protect the world’s infant population. Therefore we have been working hard on the start up of a new Viral Production Plant. This plant now comes into the phase of Process Validation. Are you the CMC Manager that can help us out with this important step in the project? Than this might be your next assignment;

It will be your responsibility to;

  • Manage the multidisciplinary Process Validation team (5 – 10 depending on the phase of the project) both as a project leader and as subject matter expert
  • Supervise the correct execution of the Process Validation in the new plant
  • Make sure all deadlines are met and reports are generated on time
  • Updating the process validation master plan and monitor the progress
  • Consultation of registration deliverables with RA & QA

Vereisten

It’s a very interesting and challenging project. You might be fit for the job if you match these criteria;

  • Master or PhD in Process Technology, Bio Chemical or related area
  • Experience in leading Process Validation teams including file changes
  • Experience with technology transfers, development studies, engineering runs and process validation
  • Experience within the pharmaceutical branch, preferably within biotechnology or vaccine production
  • A natural leader with strong communication skills
  • Able to switch between helicopter view and details
  • Able to bring parties together and knows how bridge gaps

As a person you are;

Able to start on a short term? Interested in this project for at least a year?  Then please apply now and we will get back to you shortly.

Please note that for this position (re-)vaccination is obliged.