Bioprocess Engineer USP at HAL Allergy
HALIX delivers end-to-end bioscience services for therapeutic recombinant proteins, viral vectors and vaccines.
The Bioprocess Engineer USP is responsible for the development, tech transfer and implementation of large scale production processes for GMP manufacturing of biopharmaceuticals.
- Performing experiments needed to develop and optimize process steps/processes or as follow up of trouble shooting.
- Design and execute up scaling studies to production scale.
- Develop and implement production process in line with GMP and FDA guidelines.
- Development of analytical and production documentation.
- Writing development reports.
- Initiation of change controls as well as action and reporting on deviations.
- Acting as project lead or subject matter expert in client projects or internal projects to meet the agreed deliverables in the mile stone planning.
- Process development based on the clients’ technology transfer documents and information.
- Facilitate tech transfer and implementation of production processes.
- Support production of biopharmaceuticals according to procedures and batch records.
- Accurate and prompt action or escalation on project risks.
- HLO/BSc or MSc degree in bioprocess engineering, biotechnology, molecular biology or microbiology.
- At least 5 years of experience with development and up scaling of upstream processes in mid- and large-scale bioreactors.
- Knowledge of a wide variety of both upstream and downstream processing techniques for the production of biopharmaceuticals, such as 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, under GMP/FDA guidelines in a BSL2 facility.
- Experience with equipment maintenance and qualification is preferable.
- 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:
- Customer focused, quality driven with a continuous improvement mind set.
- Proven strong scientific and project management skills.
- Strong communicator and ability to build bridges between groups and organizations.
- Able to carry out several activities and projects in parallel.
- Pro-active and solutions oriented.
- Ability to work under time pressure.
- Self-starter, hands-on, builder.
- Good knowledge of English, both verbal and written.