QC Scientist at Pharming Group NV
Pharming Group N.V. is committed to the development of innovative products for the treatment of unmet medical needs. We focus on the development and production of human therapeutic proteins to provide life-changing solutions to patients.
Based in: Leiden
Goal of the Job:
Scientifically responsible for validation, transfer and management of current and new QC assays.
Tasks & responsibilities:
Be scientifically responsible for (re-)validation and transfer of current and new QC assays for release testing of skimmed milk, DS and DP outsourced at CLOs/CMOs.
- Be responsible for QC assay management including troubleshooting of the assay and monitoring/qualification of critical materials and reference standards.
- Implement new assays within QC environment.
- Define strategy of QC related projects together with other scientists and/or line manager.
- Manage progress of assigned QC related projects in house and at CLOs/CMOs.
- Set up study plans, interpret data and report results in final reports.
- Be focal point for CLO/CMO with respect to scientific issues in the QC area.
- Perform QC related activities according to the Pharming quality system.
Education & experience:
Bachelor degree with minimal 4 years of relevant working experience or
Master degree with minimal 2 years of relevant working experience
or PhD in relevant area.
- Scientific working/thinking level, training in biomedical and pharmaceutical sciences.
- Knowledge of quality systems (cGLP and GMP) and pharmaceutical guidelines.Knowledge of validation of analytical / biochemical / biological methods.
- Good command of English both written and spoken.
Please apply via our website www.pharming.com attn. Ms. Gabriëlle Smit.
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