Bedrijfsomschrijving About the company:
Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, talented and multi-scaled people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. To build up and strengthen our Operations Team in the Vaccines Launch Facility we are looking for several enthusiastic and talented.
The operations department plays a central role within the VLF and is responsible for on time manufacturing and delivery of the planned batches against the high-quality standards and safety and compliance regulations that are applicable for vaccine manufacturing.
The operations department holds around 60 people and is divided in 4 teams. 3 Teams are responsible for the actual on time production and delivery of the batches (USP, DSP and Operations Support) and one Team (COE) is responsible to support the production teams with specialized and in-depth knowledge and skills on our production processes.
Yacht Life Sciences has a vacancy for an Operator with knowledge of the Upstream and Downstream processes (USP/DSP) at our client Janssen Biologics / Johnson & Johnson (the Vaccine Launch Facility (VLF)) in Leiden.
The Vaccine Launch Facility (VLF) is a state-of-the-art vaccines GMP manufacturing facility located at the Bioscience park in Leiden, where we produce vaccines against infectious diseases, such as HIV RSV. The VLF is designed to manufacture a drug substance on a 1000 L scale for Phase III and commercial purposes. As a response to the global COVID-19 pandemic the VLF has been appointed as one of the production sites for Janssen’s lead vaccine candidate for COVID-19.
About the role:
In this role you will perform the upstream and downstream processes in the facility, detects abnormalities and participate in problem solving and implementation of corrective actions.
Also, you will be responsible as area owner for support activities, such as tracking documentation and computer systems, "basic asset care", ensure the cleanliness (5S), maintenance of the area and equipment, sampling, transfer of knowledge etc. to ensure the new launch facility is ready to produce within EHSS and cGMP regulations.
Besides that, you will be responsible for:
Taking part in all activities related to the production of cGMP batches in the launch facility. This includes processes such as cell and virus culture, purification processes, formulation & fill and in-process testing.
Accurately completion of documentation such as batch records, logbooks, etc.
Working precisely, detecting and solving acute problems and communicate possible abnormalities.
Preparing, assemble and disassembly of process equipment for production activities.
Actively participating in setting up documentation to ensure successful production runs.
Internal organization of the launch facility, including ISL, 5S and Kanban systems.
MBO/HBO/Master degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
>1 year of relevant experience in a biotechnology or biopharmaceutical industry environment
Experience with cGMP environment and EHSS standards is preferred.
Experience with cell / virus culture, purification processes, formulation & fill and/ or in-process testing.
Terms of employment:
We offer a challenging position which allows you to work in a dynamic, international, high-tech environment, ensuring diversity in your work and creating plenty of opportunities for personal development.
This concerns a permanent contract at Janssen Biologics/ Johnson & Johnson situated in Leiden, the Netherlands.
We will offer a competitive benefit package in line with the seniority of the position (salary between €2200 and €3700 euro gross per month).