(Senior) Manufacturing Fill & Finish Process specialist
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.
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 an all-round expert in quality, regulatory, technical and business aspects of external manufacturing.
Who we're looking for
The ideal candidate has a B.Sc. or M.Sc. in pharmaceutical sciences or other relevant disciplines (i.e., pharmacy, (bio)chemistry) with at least 5 years of experience (10 years for senior position) in vaccine and/or large molecule GMP drug product manufacturing. Experience with process development, project management and outsourcing is highly advantageous.
We are looking for a person who is pro-active, flexible and full of initiative. Their highly dynamic environment requires you to have a strong work ethic, expect change and be creative. This position may require travelling and staying abroad for up to 1 week and work independently on location (when possible).
Janssen Vaccines & Prevention B.V. is part of Johnson & Johnson, one of the biggest and most respected health care companies in the world. They are dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacturing, and marketing of novel vaccines to prevent some of the most devastating and complex infectious diseases. These range from respiratory infections like respiratory syncytial virus (RSV) to human immunodeficiency virus (HIV) and pathogens of global concern, such as Ebola and COVID-19.
In this organisation, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. They are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen. The offices of Janssen Vaccines & Prevention are located in Leiden, The Netherlands.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||Project for at least 1 year.|
Days of leave: 25 + 11
See here our other employment terms for this vacancy
|Location||:||View location with Google Maps|
|+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.