Description
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.
Qualifications
The responsibilities and the impact YOU will have:
Lead deviation investigation in documenting product impact analysis and root cause investigation and timely follow up (including CPA records) and completion.
Working precisely, detecting, and solving acute problems and communicate possible abnormalities.
Support in keeping general BU5 GMP documentation up to date and provide support in improvements on production processes and systems within LVV.
Support in improvements regarding relevant Quality standards applicable to BU5 (including support in on-going Quality investigations).
Writing change controls for the GMP/ EHS systems and BU5 improvements, and responsible for follow up and timely documentation and completion.
Coordinator of documentation periodic review within the BU5 and internal batch release (WVS, IVP, DS)
Participating in quality risk assessments and leading process excellence activities to continuously improve the work as well as personal skills.
Coordinating / supporting activities during internal and external audits in the role of SME, scribe, or back-office lead.
We would love to hear from YOU, if you have the following essential requirements:
- Bachelor’s degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
- 2-8 years’ experience in biotechnology or biopharmaceutical industry environment.
- Good communication skills written and verbal in English (required) and Dutch (pre)
- Experience in Quality Systems, specifically Change Control
- Working knowledge with cGMP standards is required.
- Preferred knowledge of sterile processing, drug product filling and Annex 1 regulations.
- A preference for experience with Trackwise QEM and/or COMET, Truvault or similar automated systems.
- Knowledge and experience with Lean methodology.
This is what awaits YOU at J&J;
- Be part of a global market leader.
- Experience a dynamic and inspiring working environment.
- Opportunities for career growth and continuous personal and professional development in areas of technology and leadership.
- Personal Development Plan – such as access to further education & training, mentoring and coaching, development opportunities on-the-job or through exciting projects.
- Connect with a strong global network of talent and expertise, with opportunities to learn and move across cultures and work environments.
- Competitive benefits package including 36 holidays, a bike plan, gym allowance, all kinds of mental support for you and your family, additional
- insurances and solid pension arrangements, referral awards, jubilee gifts and more!
- Equal opportunities employer.
What type of mark will you make?
By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well as your mind. When you work at Johnson & Johnson you can touch over a Billion of lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.
Diversity, Equity & Inclusion at Johnson & Johnson means that “YOU belong”!
For more than 130 years, diversity, equity & inclusion have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued, and every one of our people feels that they belong and can reach their potential. No matter who they are.