We’re looking for an Assay Feasibility Team Lead to research and design a broad range of IVD assays for potential deployment on the Q-POC™ platform. The assay technologies utilised include sample processing methods, DNA/RNA extraction, multiplexed PCR and qPCR assay, and end-point PCR assay design and development.
A key success factor for this position is your ability to work in a fast paced, cross-functional group environment, with a focus on delivery of objectives to timelines, and a willingness to be involved across a wide area of responsibilities.
Key Roles & Responsibilities
- Lead the Assay Feasibility team of research scientists
- Deliver on a range of scientific activities leading to the successful ‘proof of concept’ MDx assay design for commercialising on the Q-POC platform
- Work with Business Development to identify and apply for external partnerships, research and grant opportunities
- Manage and track the Assay Feasibility team spend including OPEX and CAPEX making appropriate decisions to minimise expenditure while delivering on business-critical goals
- Perform technology transfer, and author appropriate documentation, to the Assay Development Group once the feasibility phase is complete
- Be cognisant of ISO13485 requirements for assay development and flag early in feasibility phase if ‘novel processes’ will impact final product
- Develop IP, keeps abreast of competitor patents and technologies and support the patent process including drafting and reviewing claims
- Apply a breadth of knowledge to both directly solve problems and guide the team through structured problem solving. Identify technical risks and proactively implement mitigation strategies and plans
- Plan, lead and manage validation activities in line with IVD regulatory requirements
- Collate and review technical files in collaboration with Quality Assurance and Regulatory Assurance to ensure completeness and to support regulatory submissions
- Continuously identify and implement process improvements
- Support business development and support publication strategies for QuantuMDx products; both internal and external generated data
Experience, knowledge and requirements
- Be a proven leader in managing and organising assay research teams of up to 5 individuals
- Hold a Ph.D. or have equivalent experience in Molecular Biology or a related discipline
- Have in depth knowledge of DNA and RNA amplification techniques, detection technologies, sample processing technologies, molecular assay design and infectious diseases
- Be experienced in the front end design of MDx assays for a point-of-care instrument and consumable platform including bioinformatics knowledge
- Manage working practices and quality within Cat 2 laboratories
- Have a track record of publishing and presenting the outcome of assay design and development activities
- Be skilled in cutting edge scientific techniques and their application to rigorous and ethical scientific research, maintaining confidentiality at all times
- Adhere at all times to the legislation, guideline and demands of the external and internal regulatory environments including working to ISO13485 and ISO14971
- Ability to work full time within the UK without restriction.
- Be experienced in point-of-care diagnostics and lab-on-a-chip microfluidics devices
- Have experience working with multiple sample matrices including blood, plasma, urine, saliva, etc.
- Have previous experience working with STIs, HPV, TB and respiratory assays
- Bring knowledge of statistics and advanced data presentation
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®