This job is located in Bilthoven
About Batavia Biosciences
The short version is that Batavia helps to optimize the route from drug discovery to clinic.
The reality is that we do much more than that: by leveraging the combination of our expert workforce, our broad, international academic and public network and our extensive range of high-end services, we design the optimal route for our customers to reach the one person that we all are 100% committed to: the patient.
To help us take biopharmaceutical development to the next level, our team would love to welcome you as an GMP technician.
About the job
The Clinical Manufacturing department is responsible for production of cell banks, virus seeds, and drug substance batches suitable for clinical studies. In the Netherlands, the processes are currently executed in Leiden and Bilthoven.
As a GMP technician you will be primarily responsible for the preparation and execution of the daily activities in the cleanrooms in Bilthoven, such as execution of the manufacturing process and the activities directly related to this, such as procedure updates, material collection, equipment calibration, housekeeping, etc.
The job requires good cooperation and clear communication with colleagues in the cleanroom, but also with QA, QC, department management and facilities. It is expected that you address opportunities for improvement and take initiative to assure a department culture of continuous improvement.
You will join an enthusiastic, international team that works in a very collaborative environment. Being part of the department, your personal as well as your professional growth are encouraged and developed.
Responsibilities
- Preparations and execution of the daily activities in the cleanroom
- Check if materials are in place and released
- Make sure equipment is in place and calibrated
- Experience with working according to Master Production Records and documenting activities in Batch Production Records
- Experience with working according to GMP guidelines / in a GMP environment
- Experience in manufacturing of USP or DSP processes
- USP experience:
- Culturing of (adherent) mammalian cells
- Preferably bioreactor experience / affinity (or a very good candidate who could potentially be trained for working with bioreactors)
- Preferably experienced in working with viruses
- DSP experience:
- Preferably clarification, chromatography, ultrafiltration/diafiltration, final filtration
- Preferably experienced in working with viruses
- Preferably experience on BSL2 level
- Support the scientist with project specific documentation
- Write independently SOP’s, Work Instructions, etc.
- Good cooperation and clear communication with colleagues in the cleanroom, but also with QA, QC, Head of Production, facilities
- USP experience:
Your profile
- BSc or MSc degree in life sciences, biochemistry, biochemical engineering or related subject
- Experience in a biotechnology or biopharmaceutical industry environment
- Experience with working in a GMP environment
- Experience 2+ years with bioreactors is preferred for technician USP role
- Experience with virus on cell-based (adherent) processes is desirable
- Good command of the English language (written and spoken)
- At least 2-5 year relevant work experience
- Demonstrated affinity with learn methodologies to support continuous improvement
You can send your application to Mrs. Ingrid van Aarle, HR Manager recruitment@bataviabiosciences.com
Application by agency or recruiters is not appreciated and will be rejected.
