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Scientist I
2 months ago
About the Role:
Yourgene Health is seeking a highly skilled Scientist I to join our Product Maintenance team at Manchester Science Park. As a key member of our team, you will play a crucial role in supporting the delivery of our product maintenance objectives through the execution of high-quality and efficient experimental work.
Key Responsibilities:
- Provide scientific expertise and input into the planning and execution of laboratory work, ensuring that experimental design and execution is robust, meets the intended aims, and facilitates clear decision making and reporting.
- Actively participate in complex projects requiring cross-functional collaboration, working closely with the Senior Scientist and Team Leader to execute work packages.
- Support the design of effective and efficient work packages and studies involving the development, planning, and implementation of protocols to show that tests meet performance and regulatory requirements.
- Ensure data integrity and traceability, generating and organizing high volumes of data, and accurately, efficiently, and timely reporting of results.
- Support troubleshooting activities when technical issues arise, and participate in post-market surveillance activities.
- Ensure own work meets regulatory & quality requirements, including compliance to SOPs, documentation using lab books, study plans, study reports, and integrity of data.
Requirements:
- First and/or higher degree (or equivalent) in a life science such as molecular biology, biochemistry, or genetics.
- 2+ years of relevant industry experience, including working in an ISO13485 environment.
- Desire to learn about regulatory requirements for in-vitro diagnostics and implementing efficient and effective studies to ensure compliance.
- Experience in the development, verification, and validation of molecular in vitro diagnostic assays.
- Experience of and confident in data analysis and interpretation.
- Experience of and confident in the preparation of experimental reports and QMS/regulatory documentation.
About Yourgene Health:
Yourgene Health is a leading integrated technologies and services business, enabling the delivery of genomic medicine. We work in partnership with global leaders in DNA technology to advance diagnostic science. Our flagship in vitro diagnostic products include non-invasive prenatal tests (NIPT) for Down's Syndrome and other genetic disorders, Cystic Fibrosis screening tests, invasive rapid aneuploidy tests, and DPYD genotyping.
We have a range of innovative DNA sample preparation platforms, powered by Ranger Technology, the Yourgene LightBench, and Yourgene QS250, ideal for cell-free DNA applications in NIPT and oncology, including liquid biopsy. Our global laboratory service network is equipped to be a full life-cycle partner for clinical, research, and pharmaceutical organizations to support partners at the preclinical, clinical, and post-market stage to develop, manufacture, obtain regulatory approval, and commercialize new products and services.
We are committed to encouraging equality, diversity, and inclusion among our workforce, aiming for our workforce to be truly representative of all sections of society, and for each employee to feel respected and able to give their best.
