We are currently recruiting for a QC Scientist to join our growing BIOCMC department in Harrogate. You would be working within our Bioassay team.
The Bioassay section is focused on the assessment of the biological activity of large molecules using cell-based assays and ELISAs. 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/ELISAs coupled with a good background in aseptic technique whilst working in a Class II facility would be advantageous in this section.
Working as part of the QC Operations Group, the QC Scientist routinely manages a number of studies pertaining to common techniques. These techniques may comprise single studies or be part of a larger study / project working in conjunction with the Scientific Lead (SL). This may include but is not limited to; (complex) validation, transfer, batch release and stability studies. They will write protocols and reports for single studies with no assigned SL. The QC Scientist has in depth knowledge in a relevant field and is able to troubleshoot techniques in the area of their expertise. The QC Scientist is accountable for the approval and integrity of the data and associated quality documentation. They are also responsible for the preparation and review of analytical procedures. In this role, the QC Scientist will provide internal Clients with a central scientific point of contact for techniques within their area of expertise. The individual is accountable for effective communication either directly with the Client or via the SL to ensure that Client requirements and deliverables are met. This involves discussion with the Client / SL to design proposals, working with the PMO, communication with the QC Section Managers and oversight of scientific progress of techniques / studies to ensure the successful, initiation, planning, execution, monitoring and completion of projects. The QC Scientist ensures that the studies are carrried out to the required standards ensuring that all work is conducted in compliance with applicable regulatory requirements (GxP). The QC Scientist is required to have an expert knowledge of the GxP and regulatory guidelines. They are the main point of contact for internal and external clients where the molecule is not overseen by the SL. Where the molecule is overseen by a SL the QC Scientist will act as the main technical contact. The QC Scientist will be responsible for overseeing the work of other QC Scientists where appropriate. They will be expected to train, coach and mentor members of the team and across functions as required. The individual will identify and communicate scientific and regulatory developments within their field expertise to the molecule management team and the wider senior scientific group (Analytical Development and QC Scientists). There is an expectation that the senior members of the QC Scientist team will be required to travel to visit clients and attend conferences, and represent Covance by preparing and/or giving presentations and writing scientific papers in their area of expertise.
• The post holder should ideally have a relevant degree and/or 5 years relevant Project Management experience.
• The ability to get things done by influencing others (both internal and external).
• An up to date knowledge of regulatory guidelines is desirable.
• Knowledge of capabilities and expertise of the Covance organisation and companies that may provide support services.
• Commercial awareness, interpersonal and negotiating skills.
• Learn and maintain knowledge of process excellence processes, tools and activities.
• Computing skills, including word processing and use of spreadsheets (e.g. Microsoft Office packages and Microsoft Project).
• An in-depth understanding of health and safety policies, Company policies and procedures, and an in-depth understanding of the GxPs
• The post holder should be able to communicate effectively at all levels with other Covance employees, as well as external clients, suppliers, etc.
•Industry experience in a relevant field.
Experience of cell culture work/ELISAs coupled with a good background in aseptic technique whilst working in a Class II facility would be advantageous in this section