Research Associate Bioanalytical Methods at Pharming Group

Introduction:

Pharming Group N.V. develops innovative protein therapeutics for the treatment of genetic disorders.  The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is small (approx. 200 employees, based internationally) and growing quickly. As a result of this growth, we are looking for a:

Research Associate Bioanalytical Methods

Overall purpose of the job:

Within the R&D department, as part of the analytical development group, you will be responsible for the development, qualification, transfer and validation of bio-analytical methods for the pre-clinical and clinical studies. Additional tasks involve monitoring the bio-analytical test results and providing support to the pre-clinical and clinical departments.

Main duties and responsibilities:

  • Responsible for the development and qualification/validation of bioanalytical methods needed for (pre-)clinical studies
  • Provide scientific oversight into the bioanalytical design
  • Support the (pre-)clinical department by monitoring assay performance and results, and reviewing bioanalytical phase plans and phase reports
  • Responsible for the technology transfer to a G(C)LP laboratory and ensure that their bioanalytical activities meet the needed quality standards and regulatory needs

Qualifications:

  • BSc or MSc in biochemistry, (medical) biology, biopharmacy or other relevant topic
  • At least 3 years of relevant experience in pharmaceutical product development; or at least 8 years relevant work experience at academic level
  • Experience in bioanalytical method development (e.g. ELISA, HPLC)
  • Experience in method qualification/validation
  • Experience with method tech transfer is preferred

Skills:

  • Experience in writing study protocols and/or reports
  • Good knowledge of English, both in word and writing
  • Accurate and flexible
  • Team player with a positive mindset

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