Analytical Assay Scientist at HAL Allergy
HALIX is a fast growing, biopharmaceutical contract development and manufacturing organization (CDMO) focused on viral vector and recombinant protein products. We have recently built a state-of-the-art GMP manufacturing facility at the Bio Science Park in Leiden that is getting filled with exciting new vaccines, antibodies and protein products. At HALIX, we support our customers with the development & commercialization of biologics enabling the treatment & prevention of life threatening conditions such as cancer, COVID-19, influenza and other infectious diseases.
Currently we are working on the production of a leading COVID-19 vaccine candidate. If you too would like to contribute to this challenging and fulfilling activity and become part of an inspiring biotech services company, then this is a perfect opportunity for you!
The Analytical Assay Scientist is responsible for the (late-stage) development, tech transfer and implementation of analytical assays to support the development and GMP manufacturing of biopharmaceuticals.
Tasks and Responsibilities
- Responsible for the development and validation of analytical assays to support development and release of biopharmaceuticals such as viral vector and proteins.
- Performs experiments and analyses experimental results. Reviews and presents data, writes study protocols, SOPs, development reports and validation reports.
- Coordinates and supervises the experiments performed in the analytical lab, is responsible for the GLP/GMP compliance.
- Owns the tech transfer and implementation of customer’s analytical assays in the various projects.
- Perform investigations on studies that have unusual results, and on out-of-trend and out-of-specification results.
- Supports the Process development team and GMP manufacturing team.
- Continuously updates her / himself with state-of-the-art technologies in the field and strives for higher scientific excellence.
- MSc / PhD degree in biology, biotechnology, medical sciences or comparable.
- At least 5 years of experience with Analytical development in a bio pharmaceutical environment GLP/GMP.
- Experience with a wide variety of analytical techniques such as HPCL/UPLC, ELISA, FACS, qPCR, TCID50, cell based assays, Western blot and Compendia methods.
- Hands-on experience with development validation of analytical methods per ICH guidelines for late stage or commercial products.
- Experience with cell culture and virus production.
- Preferably experience with Design of Experiment studies and a working knowledge of statistics.
- Experience with production of a variety of biopharmaceuticals, e.g. recombinant proteins, (viral) vaccines and antibodies, under GMP/FDA guidelines in a BSL2 facility.
- Good command of the English and language (written and spoken) and preferably Dutch.
Personal & Professional Skills
- Ability to manage small teams to complete projects with aggressive timelines.
- Professional who is self-propelling, results orientated and accurate in work.
- Strong communication and documentation skills.
- Ability to work under time pressure in a flexible, dynamic environment.
- Able to carry out seve
- We offer you a highly dynamic job in an interesting environment
- You will be working from our headquarters in Leiden, where the products are produced on site.
- HALIX offers great benefits including a competitive salary and contribution to pension and health insurance.
Applications and more information
Interested? We look forward to receiving your application. To apply, please click the "Apply" button below to the right where you will be prompted to upload your CV first.