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Sr Bioprocess Technician
Het bedrijf / The company
Founded in 2012 as a corporate venture and spin-off of HAL Allergy, HALIX is a contract development and manufacturing organization (CDMO), based in Leiden, the Netherlands. The company is licensed for the contract manufacturing of clinical and commercial medicines according to GMP standards. HALIX leverages advanced biopharmaceutical technologies and provides the full portfolio of pharmaceutical documentation of GMP production processes, as well as production of units which are required for clinical approval. HALIX, as an end-to-end service provider, will serve its customers the full range from the first development steps to start of commercial production after successful registration of products. More information is available on: www.halix.nl.
The Senior Bioprocess Technician is responsible for leading and participating in projects and for the implementation of production processes and batch manufacturing according to GMP/FDA regulations.
De functie / The role
- Production of biopharmaceuticals according to applicable regulations, procedures and batch records.
- Acting as project leader in internal projects or client projects to meet the agreed deliverables according to budget, quality and timelines. Accurate and prompt action or escalation on project risks.
- Participating in multidisciplinary project team as subject matter expert.
- Maintaining facility and equipment up to standards.
- Writing production reports.
- Writing and updating operating procedures.
- Generating and reviewing manufacturing batch records.
- Initiating change controls and leading CAPAs to resolve complex process issues.
Het profiel / Your profile
- HLO/BSc or MSc degree in biotechnology, molecular biology or microbiology.
- Knowledge about and experience with a wide variety of both upstream and downstream processing techniques for the production of biopharmaceuticals. This includes cell culturing, virus infection, chromatography, filtration, centrifugation and tangential flow filtration.
- Experience with production of a variety of biopharmaceuticals, e.g. recombinant proteins, (viral) vaccines and antibodies, etc.
- Experience in working under GMP/FDA guidelines in a BSL2 or BSL3 facility.
- Experience with equipment maintenance and qualification.
- Professional who is self-propelling, results orientated and accurate in work.
- Able to carry out several activities and projects in parallel.
- Pro-active and solutions oriented, hands-on mentality.
- Willing to work in weekends or in overtime to get the job done.
- Good knowledge of English, both verbal and written. Dutch advantageous.
Het aanbod / The offer
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.
Reactie / Reaction
Interested in this position? Please apply with the following apply link: