Overview
Cambridge Life Sciences is a well-established clinical chemistry company based in Ely near Cambridge. We produce clinical diagnostics tests that are used for medical and research purposes, globally. We are part of a dynamic and fast-moving group. Following its acquisition in 2021, the company is now gearing up for significant expansion and growth into new fields of expertise within medical diagnostics.
Cambridge Life Sciences requires an experienced technical lead to guide the team towards modern best practice in clinical chemistry product development and diagnostics services. You should be an expert in your field and enthusiastically foster the skills of your team. Knowledge of current good practice within ISO 13485 is essential, and ISO 15189 is an advantage.
Essential Requirements
• Minimum of a good honours degree in biological sciences or a related subject. A PhD or Masters degree is preferred.
• Knowledge of the science associated with the use and manufacture of clinical chemistry products, preferably within immunology, PCR, or a related specialism.
• Knowledge and experience of project management within clinical chemistry or allied field.
• Have a working understanding of Quality Management Systems particularly ISO 13485:2016.
• Familiarity with current good practice in developing clinical products to ISO 13485 or IVDR and/or providing laboratory services to ISO 15485.
• The ability to work productively, efficiently and effectively with close attention to timescales.
• A flexible and creative approach to the demands of a small business.
Key Responsibilities
• Ensure all development projects are well-managed, and run to budget and timescale.
• Manage the R&D team including professional development, performance management, team-building
• Manage the departmental budget against various projects and activities
• Manage the product lifecycle, including guiding the development of enhanced and novel products
• Work closely with the UK General Manager, Technical Development Manager and Marketing team to develop and introduce new products and services
• Provide product and application intelligence to guide product marketing
• Work with the Group QA/QC Manager to ensure existing and future products and projects meet the regulatory requirements.
• Work with the Production Manager to ensure new and existing products are produced according to best scientific practice.
• Ensure implementation and adherence to health and safety procedures.
• Investigate product failures and implement CAPAs as identified.
To apply please email your CV and covering letter, highlighting your suitability for the role, to HR@clsdiagnostics.com