Assay Development Lead
15th October 2020 | QuantuMDx Team
We’re looking for a proven leader, an expert in assay design and development, skilled in cutting edge scientific techniques and someone who can take a product from defined requirements to commercial launch.
You will be responsible for leading Assay Development at QuantuMDx and deliver a portfolio of IVD assays for commercialisation on the Q-POC™ platform. The assay technologies include sample processing methods, pathogen concentration methods, DNA/RNA extraction, multiplexed PCR and qPCR assay design and development, and end-point PCR assay design and development.
Key Roles & Responsibilities
A key success factor for this position is the 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.
The jobholder will be responsible for leading all aspects of IVD assay design and development.
They will be expected to:
- Lead and develop an extensive assay design and development team
- Understand and translate the high-level business and user requirements into a range of scientific activities leading to the successful launch of commercial assays for the Q-POC platform
- Continuously identify and implement process improvements
- Manage and track the Assay Development spend including OPEX and CAPEX making appropriate decisions to minimise expenditure while delivering on business-critical goals
- Develop IP, keeps abreast of competitor patents and technologies and support the patent process including drafting and reviewing claims
- Work with the Systems Integration team and Project Management team to identify plans, resources and schedules as well as both project and individual tasks
- 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
- Transfer assays to manufacturing and quality control and provide product lifecycle support (as required)Build relationships and projects with external evaluation partners and laboratories to gather assay performance and utility data
- 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
- 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 design and development teams of up to 20 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 taking a product from defined requirements through to commercial launch
- 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 experienced in assay performance evaluation and regulatory submissions
- 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.
- Manage working practices within Cat 3 laboratories
- 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
- Be experienced in bioinformatics and NGS
To apply for this role please send a cover letter and CV to firstname.lastname@example.org.
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 a price point accessible to both high and low resource settings.
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 or budget. 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®