Assay Development Lead
- Experience Level
Leading Medical Devices organisation requires an Assay Development Lead, the jobholder will be responsible for leading all aspects of IVD assay design and development.
Duties may include:
- 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 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.
Skills and experience:
- 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.
- 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.