Sr Bioprocess Technician at HAL Allergy
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.
- 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.
- 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.
Personal & Professional Skills
- 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.