Assay Development Scientist - Harrogate, UK
We are currently recruiting for an Assay Development Scientist for our Biosimilars team. The Biosimilars team has 14 biosimilar experts with a large expertise between them and has worked on 39 different Biosimilars project. This specialist team are developing long lasting partnerships with some of the best clients in Biosimilars. This is part of a scientific team who will be developing methodologies for Biosimilars for our clients. It is a focus area for Covance and an exciting opportunity to be part of a growing and dynamic group based in Yorkshire. We are looking for someone that has a working knowledge of Biosimilar development and must have an in-depth knowledge of analytical techniques used for antibody/protein analysis. You will engage with internal/external clients on standard and novel methodologies to characterise and set specifications for Biosimilar molecules. Knowledge of higher order techniques would be an advantage. Awareness of new technological advances with the ability to look ahead to new assays or implementation. Other duties will involve: • Has an in-depth knowledge of analytical techniques used for antibody/protein analysis, able to advise internal/external clients on standard and novel study designs and is aware of new technology developments and has the ability to look ahead to new assays or implementation. • Responsible for on time delivery targets (protocols/results/reports). • May be involved in establishing Development & Establishment scope with Client. • May produce study protocols and reports to meet client and regulatory requirements. • Responsible for Gap Analysis when Developing/Establishing methods. • Involved in start-up and ongoing study meetings. • To be aware at all times of study status and anticipate problems that may affect timing, quality etc and to work with operations taking appropriate action to resolve such problems and prioritise analysis for clients. • Provides client feedback to team. • Responsible for providing methods post establishment as confirmation of readiness for Qualification etc. • Responsible for set up of appropriate software (Softmax Pro, Empower etc) • Hosts and participates in scientific client visits • Ensures that their individual training records are up to date and accurately reflect their capabilities. • Performs any other task as may be reasonably requested by the BioCMC Management. General and Specific Analytical Skills and Techniques • Responsible for the efficient development and optimisation of study methods within the relevant group. • As required, provide appropriate technical training for staff to develop their skills and the group knowledge base. Should take responsibility for technical aspects of projects undertaken within the group, maintain track of team activity and strive to keep projects on schedule. • In depth knowledge of data processing systems. • Comprehensive understanding of routine use and maintenance of equipment appropriate to BioCMC, including trouble shooting. • To help support equipment qualification within the BioCMC Division. This may include qualification design and protocol preparation. Education / Qualifications The post holder should ideally have a relevant scientific degree and/or an appropriate amount of laboratory experience. A PhD would also be of advantage for this position in a relevant field. Experience The post holder should typically have: - Computing skills, including word processing and use of spreadsheets (e.g. Word, Excel). - In-depth understanding of Health and Safety policies, Company Policies and Procedures, a working knowledge of ISO (accreditation and application). and an in-depth understanding of the GxPs. - Should be able to communicate effectively at all levels with other Covance employees, as well as external clients, suppliers, etc.