Research Associate, Assay Development
Job Summary
The Research Associate Assay Development supports the development of rapid nucleic acid amplification-based molecular diagnostic assays by performing defined molecular biology biochemical and analytical laboratory activities under the supervision of Scientists and senior team members. The role contributes to feasibility optimisation verification validation and transfer activities by generating reliable experimental data maintaining accurate records and supporting well-controlled workflows within a regulated molecular diagnostics environment.
This position is suitable for candidates at the start of their scientific career including graduates or postgraduates or candidates with equivalent practical laboratory training or experience. Prior industrial molecular diagnostics experience is desirable but not required.
The postholder will work under supervision initially following defined protocols SOPs work instructions laboratory safety requirements and experimental plans. As competence develops the postholder may take increasing responsibility for daily laboratory organisation routine technical observations draft data summaries and contribution to troubleshooting discussions. Training will be provided for company-specific procedures equipment documentation systems biosafety expectations and quality-system requirements.
- Conduct defined molecular biology biochemical and wet-laboratory experiments in accordance with approved protocols SOPs work instructions safety requirements and experimental plans.
- Perform assay-development activities such as PCR RT-PCR isothermal amplification setup primer-mix preparation nucleic acid handling target addition serial dilutions and reagent preparation as trained and authorised.
- Prepare label aliquot store and manage reagents samples and consumables; check lot numbers expiry dates storage conditions sample identifiers and required controls before use.
- Support assay feasibility optimisation development verification validation and transfer activities under the direction of senior team members.
- Follow contamination-control practices appropriate for nucleic acid amplification workflows including designated work areas PPE controls consumables and unidirectional workflow principles where applicable.
- Handle clinical specimens and biological materials in accordance with applicable biosafety and containment requirements including use of a Class II microbiological safety cabinet where required and appropriately trained.
- Maintain an organised laboratory workspace and support equipment checks stock management consumable preparation housekeeping and safe waste disposal.
- Generate collect analyse and summarise experimental data with guidance from senior colleagues.
- Maintain complete accurate attributable legible contemporaneous original and accurate records in the electronic laboratory notebook and other controlled systems.
- Perform routine calculations and basic analysis including dilution calculations concentration calculations preparation volumes tabulation of results basic graphical summaries and simple statistical summaries.
- Promptly escalate anomalies unexpected or ambiguous results suspected sample/reagent issues deviations data-integrity concerns quality issues and safety concerns.
- Communicate experimental progress results constraints and technical observations clearly to the supervisor and project team.
- Contribute to assigned activities across assay development projects and collaborate effectively with colleagues within R&D and other functions.
- Participate constructively in project meetings laboratory discussions training activities and troubleshooting reviews.
Area | Essential | Desirable |
Education / experience | Bachelors degree in molecular biology biochemistry chemistry biomedical science or relevant discipline or equivalent practical laboratory training and experience. Practical wet-lab experience from study placement internship apprenticeship academic research or early-career employment. | Masters degree postgraduate research project or additional specialist training. Experience in molecular diagnostics life sciences medical devices clinical research or another regulated environment. |
Technical knowledge and skills | Understanding of nucleic acids amplification principles primer/probe function assay controls contamination control and routine laboratory calculations. Accurate pipetting solution/dilution preparation reagent handling and sample labelling. | Experience with PCR qPCR RT-PCR LAMP RT-LAMP nucleic acid extraction restriction enzyme digestion clinical/biological sample handling at CL2 or Class II microbiological safety cabinets. |
Data documentation and quality | Good data-recording and basic data-analysis skills including Microsoft Excel or equivalent. Strong attention to detail and ability to follow protocols SOPs work instructions safety requirements and quality expectations consistently. | Familiarity with ELNs LIMS QMS platforms controlled document systems design controls verification validation assay transfer or assay outputs such as Ct time-to-positive endpoint fluorescence using spot and population metrics. |
Communication and working style | Effective written and oral communication; ability to ask questions respond constructively to guidance work collaboratively organise assigned tasks and develop technical skills through feedback and training. | Experience preparing technical summaries presentations or lab reports. Interest in scientific problem-solving assay development molecular diagnostics regulated product development or bioinformatics-based assay design. |
Required Experience:
IC
About Company
OraSure Technologies is a global company that empowers the world to improve health and wellness by providing access to accurate, essential information.