QC Scientist

QC Scientist

Genmab

Ballerup, Denmark

The Role

Our QC lab department in Genmab is looking for a Scientist in the Equipment group to help in the building of a the GMP QC Laboratory for Genmab.

The laboratory will, when ready, be responsible for supporting Genmab´s innovative products by performing release and stability testing according to ICH guidelines.

You will play a key role in the establishment of the laboratory which includes authoring and reviewing general qualification procedures and drive all the documentation activities for qualifying and troubleshooting equipment. You will be in close contact with all Genmab´s QC SMEs.

The main tasks that this position comprise are to set up a qualification process for new equipments and to standardize the qualification process. This will include writing Change Controls, URS, IQ/OQ and PQ protocols and reports.

The position is an onsite position in our QC Lab in Ballerup and will be reporting to Associate Director, Head of QC BioAssay.

Requirements

• You hold a master’s degree in natural science, biotechnology, or similar with 2-4 years within equipment qualification and maintenance
• Experience with one ore more of the following equipment/instruments is required: Maurice, PA800, HPLC, UPLC, Spectrophotometer, pH meter, Turbidimeter, and/or Osmometer
• Familiar within GMP QC setting and in audits
• You have experience in setting up a flow for standard qualification of equipment
• Thorough understanding of the requirements for equipment qualification and you have been involved in the writing of general SOPs
• Having experience with Empower, Spectramax, Biacore and LIMS (LabVantage) is desirable

About You

• You are genuinely passionate about our purpose
• You bring precision and excellence to all that you do
• You believe in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
• You take pride in enabling the best work of others on the team
• You can grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so!