|Contact name:||Michelle Terraneo|
|Published:||25 days ago|
In our organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. We 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.
The USP department is responsible for early- as well as late-stage development of scalable, pharmaceutical-grade production processes for viral vaccines using mammalian cell lines as a production platform. Novel technologies are used to make sure that the processes are safe, reliable, scalable and cost-effective, so that the vaccines can be produced in large quantities at low costs. The developed production processes are transferred into GMP production facilities for the production of clinical batches and scaled-up for commercial production. This is done in close collaboration with many partners in Discovery, Development and Supply Chain in an international environment. Within the USP department, a lab team is responsible for performing all hands-on experimental activities, data processing and documentation, whereas a team of scientists is responsible for the overall scientific approach and progress within our projects.
• Develops and executes USP early- and late-stage development and tech transfer strategies
• Creates and manages research plans in the delivery of business results
• Represents USP in multidisciplinary project team(s)
• Acts as author in the preparation of presentations, technical reports, documents for regulatory filing and patents
• Applies the latest technological innovations into the daily work. One of the major innovations currently explored is modeling, data management and statistical analysis applied to bioprocessing
• Ph. D. degree or post-doctorate degree biopharmaceutical sciences, biotechnology, bio-process technology or related fields
• At least 2 years of late-stage biopharmaceutical experience, preferably in industry
• Technical knowledge on bioreactor process technology; ideally for R&D and/or commercial (GMP) purposes
• Experience with two or more of the following: life cycle process validation; regulatory submission writing; process improvements; multivariate data analysis; technology transfer; manufacturing support.