An exciting opportunity has arisen for an ELISA QC Bioassay Team Leader. The company manufacture biosimilar monoclonal antibodies at their state-of-the-art facilities in Reykjavik, Iceland. Within their Bioassay QC department, you will be responsible for a team of 6/7 individuals.
This company is well resourced and financed with significant growth plans.
You will be responsible for the following testing, as and when required:
- ELISA based assays
- Ligand binding assays
- Cell based assays
- Preparing working cell banks using tissue culture techniques
- Microscopy work
- Aseptic practices
You will also be responsible for:
- Play a role in the day to day management of the Quality Control department
- Help establish and maintain departmental metrics
- Lead Technology Transfers/Validations
- Review and approve, where required, generated technical documentation
- Initiating deviations, leading level 2 deviations, and supporting staff involved in level 2 and 3 deviations
- Raising and leading OOS/OOT investigations
- Minimum of a MSc in a relevant scientific discipline and direct industry experience or 5 years' experience in Pharmaceutical or Biopharmaceutical sector
- Knowledge and proven experience of working to GMP standards
- Strong QC experience
- ELISA assay experience
- Two years people management experience
Please forward your CV to Alex Butcher or phone 01403 216216 where we would be happy to tell you more about this exciting QC Bioassay opportunity.