QC Scientist

Location Netherlands
Discipline: Biotechnology
Job type: Temporary/Freelance
Contact name: Caitlin Girdwood

Contact email: c.girdwood@panda-int.com
Job ref: 10714
Published: 28 days ago

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 QC Scientist.

About The Role

The Quality Control department is responsible for the release testing of products. Release testing is outsourced to several contract partners. The main task of the QC Scientist will be management of current and new analytical test methods to support release of product for commercial and/or clinical purposes. This includes managing contract partners, trouble shooting, validation and transfer of analytical methods.

Management Of QC Testing

Areas of responsibilities:
  • Contact person for QC testing of starting materials, DS and DP outsourced at CLOs/CMOs
  • Troubleshooting, monitoring/qualification of critical materials and reference standards Analytical Life Cycle Management
  • Validation and transfer
QC Representation In Projects
  • Advice and contribute in developing/evaluating analytical methods, specifications, stability studies
  • Coordinate/execute all QC tasks within the project
  • Advice and contribute in developing/evaluating analytical methods, specifications, stability studies
  • Coordinate/execute all QC tasks within the project
Required skills & qualifications in order to be successful in this role:
  • HBO/BSc/MSc in Life Science or similar
  • Good knowledge of GMP and hands on experience with guidelines (FDA, EMA and ICH)
  • Experienced in setting up validations and or transfers of analytical methods
  • Experience in working in a QC routine production environment and GMP requirements for analytical methods
  • Experience with evaluation and setting up SST and acceptance criteria
  • Good knowledge of English, both in word and writing
  • Effective communication
  • Teamwork and coordinating skills
  • Accurate and flexible
  • Decisive and pro-activ