We’re looking for a research scientist who is hands-on and cross-functional, to support the technology development and transfer of QuantuMDx’ IVD devices, including sub-components and sub-assemblies. You will work within the Manufacturing, Science & Technology team with cross-disciplinary project-led teams, as required.
Key Roles & Responsibilities
Performing a combination, but not necessarily all, of the following duties:
- Provide subject matter expertise for R&D activities and process development of QuantuMDx’s microfluidic diagnostic platform
- Design, develop and test novel sub-component parts for inclusion into the microfluidic test cassette
- Contribute to the production of documentation including Material/Component Specifications, Validation Test Plans/Reports and Certificates of Conformity for components of QuantuMDx’s IVD devices
In addition, the research scientist role will include:
- Data collection and analysis of incoming components using appropriate characterisation techniques
- Generate, record and present complex data to line manager, colleagues, senior management and external partners
- Author technical plans and reports, technology transfer documents and prepare scientific presentations as required.
- Write/revise SOPs as needed
- Attend lab, team and project meetings and present findings
- Contribute to maintenance of the lab and equipment
- Work within the Company’s Quality Systems and Policies in line with ISO 13485 standards
- Effectively interact with other Technical and Development teams
- Liaise daily with scientists and engineers in-house and ensure excellent communication between teams and management.
- Provide support to the commercialisation activities of the company
Experience, knowledge and requirements
- A degree in Materials Science, Mechanical Engineering, Biochemistry, Chemistry, or a relevant BSc in an appropriate related discipline
- 1+ years in relevant life science or medical device industry experience
- An in-depth understanding of in-vitro diagnostics including process scale-up and technology transfer
- Understanding of analytical methods used to support diagnostic manufacture
- Ability to work cross-functionally between R&D, Manufacturing, Quality and Regulatory teams
- Experience with authoring/executing controlled documents such as test methods, SOPs and technical reports
- Experience in Root Cause Analysis techniques
- Comfortable in a fast-paced SME environment with ability to engage in a variety of projects simultaneously and handle rapidly changing information
- Knowledge of safe laboratory practice
- Meticulous record keeping
- Highly motivated, organised, proactive and enthusiastic individual with a proven ability to deliver results in a timely manner
- Team work to accomplish project objectives and goals.
- Excellent communication and interpersonal skills with the ability to work in a changing environment on complex projects.
- Ability to interact with external and internal partners on fast-paced projects
- An inherent willingness to research, develop and explore scientific methodologies and ideas in response to research and device developmental challenges
- GLP and ISO 13485 standard experience
- Maintain confidentiality at all times
- Be eligible to work full time in the UK without restriction.
To apply for this role please send a cover letter and CV to moc.xdmutnauq@tnemtiurcer.
The intent of this job description is to provide a representation and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
QuantuMDx Group is an exciting and highly innovative multinational company headquartered in the United Kingdom, with operations and partners in the United States, Asia, Europe and Africa.
The Company’s technology innovates the molecular diagnostic work-flow, enabling delivery of rapid actionable answers to complex clinical questions at an accessible price point.
The Company’s flagship device is the Q-POC™, a simple-to-use, affordable, portable sample to answer molecular diagnostic device. With its laboratory quality testing and cost-effective disposable, Q-POC™ will bring the power of precision medicine to health professionals throughout the world, regardless of location. Moreover, with its best in class multiplexing technology, it enables rapid detection of antimicrobial resistance and subsequent ‘right first-time prescribing’.
The company is developing further diagnostic platforms that may be used as standalone devices or integrated into diagnostic workflows. Products include the pathogen enricher CAPTURE-XT®