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Senior Assay Development Team Leader in Worcestershire
Our client is a leading designer and manufacturer of fully-automated ELISA microplate workstations, laboratory instruments and associated consumables and accessories. They are seeking an experience candidate to work on the Research, development and validation of solid phase panel immunoassays /ELISA based on the company’s patented bead technology.
This position involves organising a team to develop a range of solid phase panel immunoassays. You will work with fellow team leaders and managers at a higher level to ensure projects are kept on track, in particular providing supervisory cover in the absence of other team leaders. The work will comprise a combination of research & development, followed by the manufacture of production scale kits for prototype phase and the generation of prototype assay performance data.
Be responsible for the day to day running of assigned projects and supervising staff. Identify sources of clinical materials for assays and procure these for R&D purposes.
Plan daily workload for your Technicians, process & review results and write up experiments in project laboratory books and ensure original data is organised in electronic format. Data analysis will be performed using standardised spreadsheets and appropriate statistical tools.
Maintain awareness of the latest developments in the relevant product areas and interact with opinion leaders to further the company’s research capabilities, including the opportunity to attend relevant scientific meetings.
Assist in the transfer of new products into production, including training with manufacturing staff as required. Also supply the analytical trials group with information and materials.
Ensure all equipment used by your team is appropriately calibrated and maintained before use.
Ensure you and your team follow the requirements of the ISO13485 FDA quality system at all times.
Degree or higher qualification or equivalent in Biology, Biochemistry or related subject.
Minimum of 5 years experience in commercial clinical assay production and/or development in a supervisory or management capacity.
Strong knowledge of ELISA and other solid phase immunoassays.
Excellent communication skills and natural team leader.
Well organised, able to complete projects to agreed timescales.
Good innovation, logic, data analysis and trouble-shooting skills.
Able to evaluate activities within the laboratory and recommend improvements.
Knowledge of FDA or ISO13485 an advantage but not essential.