Bioprocess Engineer DSP at HALIX at HAL Allergy
HALIX is a fast growing, contract development and manufacturing company focussing on viral and recombinant protein products. We have recently built a state-of-the-art facility including development labs at the Bio Science Park in Leiden that is getting filled with exciting new vaccines, antibodies and protein products. These products often require (late-stage) development using the latest (single-use) technologies. At HALIX, we enable our customers to find cures for impactful diseases.
As the Bioprocess Engineer DSP you will be working in our growing development team, in close collaboration with the production team and you will be reporting to the Director Manufacturing.
The Bioprocess Engineer DSP is responsible for the (late-stage) development, tech transfer and implementation of DSP processes and providing DSP technical support for GMP batch manufacturing of biopharmaceuticals.
- Translate lab scale customer DSP processes to phase I/II/III clinical trial batch using ‘Quality by Design’ principles and ‘single-use’ technology
- Own the tech transfer and implementation of customer’s production DSP process during the project phase
- Performing experiments needed to develop and optimize process steps/processes or as follow up of trouble shooting
- Generation and review of manufacturing batch records. Support production during initial GMP batches in the clean room. Writing development and initial production reports
- MSc degree in bioprocess engineering, biotechnology, or comparable
- At least 5 years’ experience with DSP development in a bio pharmaceutical production environment. Knowledge of a wide variety of downstream processing techniques
- Experience with production of a variety of biopharmaceuticals, e.g. recombinant proteins, (viral) vaccines and antibodies, under GMP/FDA guidelines in a BSL2 facility
- Knowledge of analytical assays and bio-assays is preferable
- Good command of the English and language (written and spoken) and preferably Dutch
Personal & Professional Skills:
- Professional who is self-propelling, results orientated and accurate in work
- Ability to work under time pressure in a flexible, dynamic environment
- Able to carry out several activities and projects in parallel