For this renowned Biotech I am looking for a Technical Specialist acting as a key person for QC in complex issue handling and complex activity performance. Experience with cell culture, assay qualification and Elisa is required.
- Have knowledge about instrument and assay
- Handles complex issues (method or instrument related)
- Supports TT and TD&I during tech transfer for his/ her knowledge field
- Describes validation and performance qualification of instruments
- Provides support and training for QC methods
- Give input in OOS investigations, NCs, CRFs or CAPAs
- Take responsibility for the completeness and quality of activities linked to the applicable expertise
- Involved in training of QC associates but the position does not involve supervisory tasks.
- Master or BSc in biological, medical-technology or pharmaceutical sciences with preferably working experience in a GMP regulated environment.
- Strong know-how and Experience with cell- and micro-based assays is required, depending on the specialty (preferably +5 years of experience).
- Strong experience in Elisa
- Experience in FACS (Fluorescence-Activated Cell Sorting) – cell culturing is a strong plus.
- General laboratory – and documentation experience is recommended.
- Strong GMP knowledge, knowledge about applicable guidelines and Quality awareness.
- Strong communication skills in English
- 1st of March 2021
- 6 months with high change of extension
If you’re interested in the above description, please apply with your CV by clicking on the ‘apply’ button. For further information, please contact Merel van Os at +31 (0)20 20 44 502 or by email at firstname.lastname@example.org