GMP Specialist
Date de publication :
15 octobre 2024Taux d'activité :
100%Type de contrat :
Durée indéterminée- Lieu de travail :Johnson
Johnson & Johnson is recruiting a GMP Specialist to join our Operational Readiness team in Sassenheim.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Project Pollux is the establishment of a new Janssen Supply Chain Lentiviral Vector (LVV) production facility in Sassenheim, the Netherlands to be organized as a new business unit for Janssen Biologics (JBV). This biologic manufacturing facility is intended to become a key supply option for commercial LVV in support of the global J&J Innovative Medicine BCMA CAR-T program for multiple myeloma, a disease affecting ~160,000 patients annually.
Check out where we are located
The project team is preparing to get ready for commercial production in 2025.
Are you ready to be part of something groundbreaking? Do you want to make a real impact on patient lives? Are you passionate about innovation and teamwork? Then, we want you!
What you will be doing:
You will play a crucial role in supporting this new facility now and in the future.
In full operation, Shift Operations manufactures the Lenti Viral Vector for our customers. This process is following different steps from cell expansion, virus production and clarification to automated filling and labelling. The process is performed under strict GMP and BSL2 conditions. During the project the team is preparing the plant for operations and supporting the technology transfer from R&D by developing procedures and training, and the team will produce test and qualification batches.
The operation department is divided into three principal areas: The Upstream Processing (USP), Downstream Processing (DSP) and Fill & Finish Processing Department (F&F). The USP department is about the culturing of cells, transfection, and clarification. The DSP department purifies the product using various techniques, partially in aseptic process. The F&F department fills vials with the final product, then vials are visually examined and automatically labelled. In addition, the Centre of Excellence (CoE) is supporting the operational departments.
The responsibilities and the impact YOU will have:
- The CoE team contains several specialities like GMP, Training, Digital & technology, and Materials. The CoE team members are the subject matter experts and build the bridge between operational needs, and its (external) stakeholders, like Quality, Execution Systems (ES), IT, and vendors.
- During the project phase you will work on the technology transfer from R&D to manufacturing. You will participate manufacturing readiness initiatives of new equipment and processes. This includes process documentation, training, and qualification.
- As soon as the facility is in operation you will further develop the manufacturing process to achieve a stable and reliable operation. You will develop site performance management tools, facilitate investigations, and develop safety and compliance follow ups (CAPA).
- The GMP specialist is responsible for the general GMP related items for the LVV and supports the production team and the rest of the LVV with specialized and in-depth knowledge and skills on the GMP processes and systems.
Contact
Synthes GmbH