Senior Assay Development Team Leader

Job Summary: Research, develop and validate solid phase panel immunoassays based on Dynex M² bead technology. Maintain detailed and accurate records of the development work carried out, including preparation of the end of phase performance data reports. The Senior Team Leader will support other teams in the absence of their specific team leader.

Essential Functions: This Senior Team Leader position involves organizing 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.

You will work in both a hands on and supervisory role comprising of a combination of research & development, followed by the manufacture of production scale kits for UK prototype phase and the generation of prototype assay performance data. The post holder will be responsible for the day to day running of their assigned projects and supervising their staff. You will be expected to identify sources of clinical materials for your assays and procure these for R&D purposes. You will plan daily work for your reportees, process & review results and write up experiments in project laboratory books. All relevant assay records will be maintained as paper copies and original data organized in an electronic format. Data analysis will be performed using standardized spreadsheets and appropriate statistical tools.

You will be expected to be aware of the latest developments in the relevant product areas and to interact with identified opinion leaders to further Dynex’ s research capabilities. There will also be the opportunity to attend relevant scientific meetings

Other duties will include:

• For the assigned assays follow the Assay Development Design Control procedure and generate all documentation and reports as required for this using the company’s templates where required.
• 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.
• You will ensure all equipment used by your team is appropriately calibrated and maintained before use. Your staff will participate in the regular maintenance and calibration of laboratory equipment in line with the equipment requirements, as well as sharing in general laboratory duties.
• You will follow all appropriate health and safety guidelines and COSHH regulations pertinent to the projects you and your team are working on.
• You will ensure your staff are appropriately trained in all aspects of the work they undertake and will maintain records of training to demonstrate compliance to the appropriate standards.
• The post holder will comply with the requirements of the ISO13485/FDA quality system.

Supervisory Responsibilities: Two Assay Development Technicians and cover support for the other technicians.

Success Factors:

Complete projects within agreed timescales and highlight any issues promptly.

Clear and concise reporting both verbal and written.

Conduct open and honest communications.

Clear evidence of self-motivation, flexibility and a drive to learn and contribute to the success of the business.

Strong leadership and ability to work in a team environment.

Good innovation, logic, data analysis and trouble-shooting skills.

Demonstration of excellent organizational & time management skills demonstrated through working effectively to tight deadlines and through supporting other teams as required.

Excellent record keeping and the ability to accurately follow set procedures, working with a consistently high degree of accuracy and attention to detail.

Able to evaluate activities within the laboratory and recommend and initiate improvements.

Contribution of innovative ideas for future projects.

Minimum Qualifications / Education: BSc or higher Degree or equivalent in a relevant scientific discipline, with minimum 5 years’ experience in commercial clinical assay production/development in a supervisory or management capacity.

Computer Skills: MS Office proficient.

Work Environment: Medical diagnostic research laboratory and office.