Senior Bio process Technician 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!
As a Senior bioprocess technician at HALIX, you will be working on USP, DSP as well as aseptically fill processes. You will lead the tech transfer from late stage development into GMP production together with a team of bioprocess technicians and operators.
In the position of Senior Bioprocess Technician you will be responsible for the implementation and execution of often new manufacturing processes according to GMP/FDA regulations.
Furthermore the following tasks and responsibilities are applicable:
- Preparing the manufacturing processes: cleaning equipment, requesting and checking the manufacturing documentation, reviewing log books, checking the equipment-status and ordering materials required for the process.
- Take accurate and prompt action or escalation on quality related issues.
- Execution of manufacturing processes of cell cultures, infection of the cells, harvesting, clarification including downstream processes. All according to GMP/FDA-guidelines, internal procedures, protocols and batch records.
- Closing out of the manufacturing: line clearance, equipment or area decontamination and change over.
- Writing and reviewing of manufacturing batch records.
- Equipment maintenance and qualification.
- Possibly lead a team of bioprocess technicians and operators
- BsC in biotechnology, microbiology or related fields
- Minimum of three years’ experience in cell culturing and/ or aseptic processing under GMP/FDA regime
- Experience with writing quality documents (e.g. batch record documentation, deviations, changes, etc.)
- Specific experience with USP is highly preferred
- Specific experience with single use technology for large bio reactors is preferred
Personal & Professional Skills
- Flexible and able to adapt in a dynamic environment
- High degree of accuracy, quality oriented
- Basic knowledge of Dutch and basic knowledge of English, verbally and written
- Pro-active, and able to work under time pressure.
- 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.