Release and Stability Coordinator/ Senior Associate Scientist
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 with Corona being the most prominent right now. 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, Covid, Ebola, HIV and RSV.
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.
The Quality Control Development (QCD) labs group is part of the Analytical Development (AD) Department of the Vaccines Process & and Analytical Development (VPAD) sector. Overall, the QCD Labs unit consist of 6 sub-teams (Raw-Materials, Sample Management, Cell Culture, Microbiology, Coordination and Release and Stability) and is responsible for release and stability testing as well as the corresponding reporting of Janssen’s virus and antibody products for use in clinical trials and the analytical support of the pilot plant activities.
The QCD Labs group focuses on supporting production and laboratory activities with:
• Release and Stability team is responsible for all internal release and stability testing (R&S team)
• Inspection, release and change management of incoming production raw materials and laboratory chemicals (Raw-Materials Team)
• Sample and Material receipt, handling, storage and forwarding (Sample Management Team)
• Cell Culture services where cells are maintained used for assays and production cell line quality is supported (Cell Culture Team)
• Microbiology group mainly responsible for maintaining controlled state of production clean room and production utilities by environmental and utility monitoring programs (Microbiology Team)
• Coordination of Release and Stability testing and Outsourcing Coordination (Coordination Team)
We are searching for a suitable candidate to reinforce our coordination team as release and stability coordinator with main focus on support to our release and stability process of our vaccines. As coordinator you are responsible for the coordination of the release of batches from requesting samples to reporting of the certificate of the Analysis (CoA). Additionally, you coordinate the start of the stability studies of our batches. you will be the single point of contact for the relevant stakeholders such as our production sites, project managers and stability scientists. You are able to work in an ever changing environment with short timelines. You are able to work closely with your fellow coordinators and together bring the team to the next level.
Your main tasks and responsibilities will be:
• Accountable for the proper coordination of our release process and initiation of coordination of stability studies.
• First point of contact for key stakeholders
• Acts as primary and/or subject matter expert for Quality during regulatory inspections, internal and external GMP -audits.
• Ensure compliance with quality standards (GMP) and production schedules.
• HBO level in a life science study
• 5-10 years of experience in a pharmaceutical environment
• At least 5 years of relevant experience in process coordination
• At least 5 years of GMP experience
• Able to prioritize own work
• Able to translate input from many different stakeholders into a concise and clear document/ process.
• Experienced with laboratory management systems or at least decent computer skills.
Flexible and accurate
• Well-developed interpersonal skills and able to build strong relationships
• Highly proficient in spoken and written English. Dutch is considered a strong plus.