The main purpose of the Fill/Finish process development specialist is to set up the plans for process development, process characterization and process validation activities for the Drug Product manufacturing process. This needs to be done according to the project specific timelines and in compliance with applicable quality and regulatory standards. The related responsibilities focus mainly on late stage process development activities and process performance qualification until planning for Continued Process Verification as part of Life Cycle Process Validation.
In this position you will operate as the interface between Janssen Vaccines & Prevention Leiden and the (external) Drug Product manufacturing sites.
Responsibilities• Accountable for the setup, reporting and timely execution of (outsourced) process development, characterization and validation activities
• Responsible to ensuring close collaboration with the FFP manufacturing specialist and ensuring alignment with project needs through Technical Integrator
• Responsible as technical subject matter expert in case product or process specific assessments are required
• Responsible for timely informing/escalating issues as needed
• Responsible to provide input and review the required documentation which will be included in the filings
• Responsible for establishing and maintaining a trustful and professional relationship with the external partner (if applicable)
• In case studies are outsourced, responsible for review of the documentation prepared by the external partner that is required for process development, characterization and validation
Our client is a professional Pharmaceutical and Biotechnology organisation, based in Zuid-Holland Netherlands. Janssen Vaccines is committed to developing first-in-class or best-in-class vaccines for some of the world’s most life-threatening infectious diseases. We have built a dedicated, world-class, multi-functional team across a variety of disciplines to develop a promising vaccines pipeline. In Leiden, we have a workforce of 700 scientists and support staff, 45% of our employees has a nationality other than Dutch with over 20 nationalities represented. We partner with many of the world’s leading experts, academic and clinical institutions and other pharmaceutical companies for the development of vaccines against, for example, Ebola and HIV.
In our organization entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen Vaccines.