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. 

Responsibilities

  • 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.

 Qualifications

  • 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.

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