Laboratory based, within the cell-based bioassay QC laboratory within the Cell and Gene Therapy Therapeutic area.
QC Scientist (Biologics / Bioassays)
Competitive Salary + Bonus + Benefits
Based in Hertfordshire
Do you have experience in Bioassay testing supporting biopharmaceutical product development or manufacturing?
Would you like to work for a large international pharmaceutical company?
My client is a leading pharmaceutical research company with a global footprint. Due to expansion and a key development project, they are looking to hire a QC Scientist (Biologics / Bioassays) to work within Quality Control supporting biopharmaceutical Cell & Gene therapy, drug discovery, development and production.
The role of the QC Scientist (Biologics / Bioassays) is to work in the cell-based bioassay QC laboratory within the Cell and Gene Therapy Therapeutic area to support the development of suitable Cell based assay methods that can support both process development and manufacturing of cell and gene therapy products.
You'll need to work with minimal supervision, interpret analytical data in regards to acceptability and consistency and set up and maintain analytical instrumentation.
Key responsibilities of the QC Scientist (Biologics / Bioassays) will include:
- Test samples utilising a range of biological cell based tests, in accordance with regulatory requirements and agreed schedules.
- Routine cell culturing to support bioassay testing in accordance with regulatory requirements and agreed schedules.
- Responsible for the condition and maintenance of the laboratory equipment, ensuring records are maintained of any calibration, maintenance.
- Maintain detailed laboratory records in accordance with current Good Manufacturing
- Provide information on biochemical methods, test specifications and sampling regimes, and the impact they may have on the product.
- Assist with investigations in product and test anomalies and out of specification results.
- Deliver and assess formal training programmes for staff and trainees as required.
- Facilitate the ordering of laboratory consumables to ensure efficient running of the laboratory and responsible for the safe storage and/or disposal of test samples, reference materials and reagents following set procedures.
- Write, review and update SOPs and associated pro-forma used within the laboratory, prepare draft method of analysis and SOPs when new techniques are introduced in the area.
- Participate in the validation of test methods and equipment used in analysis to meet regulatory requirements.
To be considered for the QC Scientist (Biologics / Bioassays) position, you'll need the following skills and experience;
- Experience with bioassay testing of pharmaceutical productsBSc in biology, cell biology, virology, biochemistry, pharmaceutical science, or related scientific discipline.
- Experience of running laboratory techniques such as cell culturing, cell based assays, bioassays, PCR and ELISA
- At least a minimum of 2-3 years of biological or bioassay analytical testing experience, ideally within a GMP, GLP or similar environment although full training will be given.
- Strong organisational and excellent interpersonal communication skills.
- Individual should be capable of writing reports related to work completed in laboratory.
- Demonstrable ability to work in multi-disciplinary, multi-cultural teams.
Key Words "QC Scientist, cell culture, cell based assays, bioassays, PCR, ELISA, QC, Quality Control, GMP, Pharmaceutical, Biologics, Scientist, Cell Therapy, Gene Therapy, Cellular Therapeutics"
Please apply online or call Neil Walton at SRG on 02030964706.