Research Associate

Research Associates drive and manage their projects from concept through R&D and hand over to production. Their skill set will include exceptional aseptic technique in tissue culturing and be able to perform immunohistochemistry as well as microtomy. The main projects consist of developing standardised cell line controls for immunohistochemistry and in situ hybridisation. Your tasks and work will be conducted in line with our ISO13485 quality management systems and you are expected to be experienced in developing IVDR products. You will work closely with all departments within the company but in particular QA/RA and Production.

The successful candidate will be involved in collating Technical Documentation required for the Technical Files and taking ownership of this aspect of the project specifically linked to Annex II of the IVDR requirements. Prospective applicants will have had previous involvement with design information, general safety and performance requirements, risk, product verification and validation and stability for IVDR. It will be highly desirable if they have been involved from start to finish in developing an IVDR product for market.

Other works in R&D include investigational work with existing products exploring additional utilities as well as exploring the potential of novel targets and technology. There will also be contract work for clients.

It is a full-time position and salary is negotiable but subject to experience.

Key Roles and Responsibilities:

• Reports to the CEO.


• Develops product concepts aligned with customer needs and product specifications.


• Plans, designs, and executes advanced independent or multi-disciplinary research/development experiments.


• Manages projects, provides scientific/technical direction.


• Prepares timelines and assessments of project progress and critical factors, and establishes priorities. Assumes responsibility for timely completion of projects, and resolves technical issues.


• Responsible for the transfer of technology and documentation from Research to Development and/or to Production. Provides information and assistance to other departments to support product scale-up, manufacture, launch and sales.


• Communicates progress of efforts to the CEO and other departments to assure awareness of current status of projects. Provides top line review of experimental results, and secondary review of experimental data.


• Prepares comprehensive written and verbal project status reports, and written manuscripts for publication in some cases. Presents findings or comprehensive project status reviews at internal & external meetings. Applies advanced technical writing skills to produce reports and documents.


• Influences senior management decisions that have an impact on business direction of their area.


Job related experience


• Minimum experience of 3 years in the research and development of clinical diagnostic or Life Sciences products - particularly the tissue diagnostic market.


• Familiar with regulatory requirements - CE IVDR, FDA, UKCA etc.


• Ability to quickly develop trust and working relationships with both internal and external stakeholders.


• Team player able to communicate effectively in a manner consistent with professional etiquette with all levels within the Company and with the Customer base.


• Strong track record in prioritizing and simultaneously managing multiple projects (activities) in a fast-paced environment for timely completion of projects.


• Ability to achieve goals with minimal to moderate supervision and direction.


• Strong professional and interpersonal skills to effectively operate on a national/international basis (i.e., aptitude for working with diverse groups and appreciation of business)


• Basic data management skills, i.e. Microsoft Office


• Excellent presentation skills


• Excellent personal communication skills, open to discussion and constructive criticism


• Free to travel internationally


Desirable:

• PhD in a related field


• Experience of the histopathology market


• Familiar with digital pathology and application of image analysis and AI learning


Applicants must have the permanent right to work in the UK