Senior Assay Development Team Leader
West Midlands, upto 60K salary
Job Summary: To develop, produce and validate solid phase panel immunoassays
- This team leader position involves working in both a hands on and a management role
- Making, testing (running manual ELISA and Multiplier assays) and optimizing assay components to work in a multiplex format; the production and QC of manufacturing sized lots; and the generation of data to support and validate the assay’s performance.
- Analyzing and presenting data including the use of standardized spreadsheets and appropriate statistical tools; generation of specific data tables and reports, and the assessment of the data’s validity.
- Ensure that scheduled maintenance, calibration and validation of laboratory equipment is carried out
- Ensure there are sufficient working stocks of raw materials.
- Work on a rota to inspect incoming raw materials
- Contribute to other essential general laboratory functions and ensure their working environment is kept organized and clean.
The team leader will be required to demonstrate a flexible and organized approach in order for them and their team to achieve the wide range project specific and general laboratory tasks within the required and agreed timescales.
All work is to be reliably & meticulously completed according to the relevant written procedures and the principles of good laboratory practice, in accordance with current FDA and ISO 13485:2016 requirements.
The post holder will be responsible for ensuring all work is precisely recorded at all times using the appropriate paper or electronic systems.
They will maintain up to date records of their health & safety and job specific training, and be able to demonstrate competence in these.
Specific team leader responsibilities
- Plan the daily and weekly activities of you and your staff to ensure that your project, and all the other required work to meet the above listed essential functions, is carried out on time and to the required standard. You will work with other team leaders and managers at a higher level to ensure the wider aims of the UK laboratory can be achieved.
- You will be ultimately responsible for the ensuring the following (relating to you and your reportee’s activities)
- All relevant Standard Operating Procedures, including for Health and safety are meticulously adhered to at all times
- All appropriate training has been received and competency achieved & documented
- All documented records (both paper and electronic copes) are accurately completed and filed.
- All equipment used has passed the calibration, maintenance and validation requirements and is fit for use.
- All data has been accurately processed, reviewed and written up in laboratory books or as supporting reports.
- Suitable raw materials are available for each stage of your project. This includes identifying, ordering and controlling stock levels of project specific materials
- Overseeing the manufacture and QC of production sized batches for clinical trials.
- Assisting in the analytical studies phase.
- Facilitating the transfer of new products into production, including training with manufacturing staff as required
- Provision of cover support in the absence of the UK R&D Director.
- Provision of cover support to the other teams in the absence of their team leaders.
- Awareness of the latest developments in the relevant product areas and the ability to interact with identified opinion leaders to further Dynex’s research capabilities. You will have the opportunity to attend relevant scientific meetings.
Supervisory Responsibilities: Minimum of two Assay Development Technicians and cover support for other team leaders
Minimum Qualifications / Education: BSc or higher Degree or equivalent in a relevant scientific discipline, with signifivant experience in commercial immunoassay production/development in a supervisory or management capacity. Significant experience of working to FDA and ISO 13485 requirements.
Computer Skills: MS Office experience, particularly Excel