Jobid=455e79c72ec5 (0.0565)
About Batavia Biomanufacturing
At Batavia Biomanufacturing we are taking an ambitious next step: establishing a brand-new, high-end manufacturing facility in Leiden. This facility is designed according to the latest standards and offers the space to develop and produce advanced vaccines, viral vectors, and other biomedical products.
Our mission is clear: to accelerate and enhance the development and manufacturing of life-saving biotechnological products. If you believe in innovation, quality, and making an impact, this is your opportunity to help build the success of Batavia Biomanufacturing.
About the position
As a (Senior) DSP Technician, you will be responsible for independently executing complex Downstream Processing (DSP) operations within a GMP-compliant environment.
Earlier this year, we moved into our new state-of-the-art facility, and in this initial phase, you will play an important role in further establishing and shaping the department. Once production is fully operational, you will take on a key role in both the hands-on execution and the documentation of manufacturing processes. In addition, you will actively contribute to knowledge sharing and training within the team.
Area of Responsibilities
Operational
- Setting up and executing the purification of clinical and large scale mammalian cell culture harvests as part of the manufacture of recombinant medicinal products including therapeutic proteins, viral vectors and vaccines.
- Performing downstream processing activities with Chromatography skids, TFF systems and other systems, including handling of viruses.
- Ensure availability of DSP materials needed for the execution of the GMP process.
- Ensure equipment availability for the execution of the process.
- Execute the downstream production processes up to storage of products/intermediates, according to production batch records.
- Perform activities according to GMP guidelines.
- In case needed, participate in the execution of engineering run and R&D processes to facilitate the technology transfer from R&D into production facility.
- Participate to maintain safety procedures for the production facility.
- Contributing to problem solving efforts and root cause investigations to resolve deviations related to equipment, processes or products.
- Demonstrating a strong focus on continuous improvement & efficiency, identifying and completing improvement projects.
- Perform daily, weekly and periodic cleaning of surfaces and equipment.
- Demonstrate a safety first mindset with a focus on adherence to EHS procedures.
Required skillset/experience
- Several years of experience in a GMP manufacturing environment:
- Familiar with adhering to GMP behavioral standards
- Highly accurate in documentation
- Extensive experience with DSP techniques
- Experience in drafting and/or reviewing batch documentation
- Ability to independently perform complex DSP processes
- Experience with viruses is preferred
- Leadership or coaching skills are a plus
- Experience in the start-up phase of a new facility or CDMO is a plus
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