QC Analyst/Experimental Officer (BioPharm CMC)
2 days left
- Full Time
COVANCE is one of the world’s most comprehensive and experienced contract research organizations (CROs) with a tradition of innovation in the science and processes of drug development. We have the ability to offer wealth of services covering all aspects of drug development ranging from non-clinical research services through to post-marketing safety and commercialization services. We are currently the only CRO with this depth of service offerings.
The BioCMC solutions Division, situated in Harrogate, North Yorkshire was established 20 years ago and is a fully GMP/ GLP/ GCP compliant facility providing a comprehensive portfolio of services including cell bank production and storage, cell bank and viral vector safety testing, viral clearance services, cell based bioassays, biodistribution studies, analysis of biofluids using immunochemistry based techniques and extensive protein chemistry support including cGMP batch release and stability testing.
Recent major investments have been made in facilities on the Harrogate site and successful candidates will be part of our exciting and expanding future, working with progressive management, inventive technologies and alongside other talented scientists.
QC Analyst/Experimental Officer – BioCMC Solutions
QC Analysts are laboratory based analysts who are responsible for performing a wide variety of assays within a regulatory compliant laboratory. Due to the varied nature of the scientific work involved, candidates must be able to demonstrate a flexible approach to laboratory work, possess excellent communication and time management skills and be able to maintain a high standard of record keeping.
The BioCMC solutions division has four sections of analytical focus, in which candidates could be required to work within:
Cell Based Assays
This section is focused on the assessment of the biological activity of large molecules using cell-based assays. The accurate determination of the potency of a drug is necessary to release manufactured batches of the drug, assess stability (shelf life) and evaluate the impact of changes in manufacturing process or in formulation. Cell-based assays are also used as part of the immunogenicity assessment of the of large molecule drug to detect the presence of neutralising anti-drug antibodies that may be elicited in toxicology and clinical trials trial subjects in response to biological drug administration. A wide variety of cellular, biochemical and ligand/ receptor binding assays are used. The endpoint determinations of these assays include, but are not limited to; Fluorescence, Luminescence, ELISA, Flow cytometry, electrochemiluminescence (MSD) and FRET. . Experience of cell culture work coupled with a good background in aseptic technique whilst working in a Class II facility would be advantageous in this section
Protein Chemistry and ELISA
These two sections combine to focus on providing analytical support in the drug development pathway for the characterisation and stability assessment of large protein molecules, including: vaccines, antibodies, cytokines and growth factors. The accurate characterisation of a drug is necessary to release manufactured batches of the drug, assess stability (shelf life) and evaluate the impact of changes in manufacturing process or in formulation. This is achieved using a variety of analytical techniques such as: SDS-PAGE, Western blotting, Isoelectric focusing, Capillary electrophoresis, HPLC, spectrophotometry, ELISA, amino-acid analysis, peptide mapping, and Glycosylation analysis.
The Biosafety group perform a wide variety of molecular and virological techniques in support of the drug development process, including, but not limited to: extraction of nucleic acids from a variety of biological matrices and analysis by PCR/ QPCR, gel electrophoresis, QF-PERT and genetic sequencing. Other assays include in-vivo and in-vitro screening for adventitious agents, haemadsorption/haemaggluttination, mycoplasma testing, virus plaque and TCID50 assays; in addition to viral clearance/ process validation studies. Experience of cell culture work coupled with a good background in aseptic technique whilst working in a Class II facility would be advantageous in this section.
HPLC experience needed.
- Candidates are expected to have a background in the life sciences area and should ideally possess practical experience of a relevant subject. A sound working knowledge of ‘Good Laboratory Practice’ and ‘Good Manufacturing Practice’ (GLP/GMP) would be advantageous.
- There are excellent promotion prospects and positions are available at all levels depending on qualifications and experience.
- Candidates will be considered from a range of backgrounds; Bachelors/Masters degree, Ph.D or those with industrial experience would be considered appropriate for the position.
- HPLC experience needed.