COVANCE, Harrogate, UK.
Covance is one of the world’s largest drug development services companies with more than 11,000 employees in 60 countries.
Due to continued investment in the BioCMC Solutions Division, we have a number of new and exciting opportunities for experienced Analysts, Scientists, Senior Scientists, Analytical Team Leaders and Section Mangers within the following teams.
In working in BioCMC you will be helping develop new medicines and bringing them to market. In our analyst roles you will be encouraged to develop a broad understanding of biologics analytical techniques and will have opportunity to develop into a Scientific specialist. Our QC Scientists work hand in hand with clients to develop state of the art techniques and to ensure that development milestones for a product are met (characterisation, clinical trial material release, assessment of stability, preparations for product filings). Lead Scientist roles define the overall analytical control strategies for product development programs and have overall responsibility for the analytical development activities for the product within Covance. The role of a Section manager is to manage the overall output within one of our scientific groups with accountability for client deliver, regulatory inspections, resourcing and overall productivity within the group.
BioCMC covers a large analytical range of techniques within our four sections: Molecular Biology, Bioassay, LC and CE groups..
Molecular Biology and Virology
The MBV 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. 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.Strong focus on Cell and gene therapy products and supporting biodistribution studies.
Responsible for the operational management of the section
The primary role of the Section Manager will be to ensure all operations within their section meets client’s deadlines, is carried out according to relevant regulatory standards (GMP/GCP/GLP) and is conducted in an efficient and financially effective manner.
The Section Manager will interact with Snr leaders within the BioCMC business and will frequently be a representative for Covance BioCMC with clients to support new business or continued relationship management.
The Section Manager will manage both laboratory supervisors and scientists and will have overall accountability for the quality of data produced within the section. The role will entail the development and advancement of scientific knowledge and processes within the Quality Control laboratory.
The Section Manager will liaise regularly with other section managers in the management of a flexible resource pool within the Quality Control function.
Through the focus on operational, quality and timeline metrics the section manager will work to ensure the financial performance of the section enables BioCMC financial budgets to be achieved and as such has substantial financial responsibility for the running of their section.
The post holder will ensure adherence to the BioCMC SOPs and will be responsible for completion of all relevant documentation.
PhD in Chemistry/BioChemistry/Virology or related science, or equivalent related degree, plus 5 years relevant experience including supervision. Experience may be substituted for education.
Extensive knowledge of regulations, preferably in a contract laboratory environment.