About Yourgene Health
Yourgene Health is a leading integrated technologies and services business, enabling the delivery of genomic medicine. The group works in partnership with global leaders in DNA technology to advance diagnostic science.
Job Title: Senior Scientist
We are seeking a highly skilled Senior Scientist to join our Product Maintenance team at Yourgene Health. As a Senior Scientist, you will be responsible for leading the delivery of product maintenance projects, providing scientific and technical leadership, and ensuring compliance with regulatory requirements.
Key Responsibilities:
* Provide scientific and technical leadership on projects, planning the delivery of Product Maintenance projects.
* Lead and participate in complex projects requiring cross-functional collaboration.
* Support the resource planning activities of the Product Maintenance Team leader and other Team and Project Leaders as required.
* Lead the authoring of QMS documentation, including product technical files and risk files to meet regulatory requirements.
* Design effective and efficient work packages and studies involving developing, planning, and implementing protocols to show that tests meet performance and regulatory requirements.
* Ensure that experimental design and execution is robust, meets the intended aims, and facilitates clear decision making and reporting.
* Provide accurate, concise, and independent data interpretation, factoring in systems-level thinking.
* Accurate, efficient, and timely preparation and review of documentation.
* Presentation and dissemination of results to the wider R&D team, Yourgene Health, and external parties, as required.
* Lead troubleshooting activities when technical issues arise.
* Maintain up-to-date knowledge, including any upcoming changes, of relevant clinical guidelines/recommendations, e.g., IVDR or FDA, to ensure products remain in compliance.
* Provide advice to other project teams in the planning and execution of validation and verification studies.
* Participate in post-market surveillance activities.
* Establish and develop external relationships, including through grant applications, KOLs, consultants, and partners.
* Ensure own work meets regulatory and quality requirements, including compliance to SOPs, documentation using lab books, study plans, study reports, and integrity of data.
* Ensure own work and that of junior staff is performed in line with company goals.
* Support and provide guidance to junior staff.
Requirements:
* First and/or higher degree (or equivalent) in a life science, such as molecular biology, biochemistry, or genetics.
* 7+ years of relevant industry experience, including working in an ISO13485 environment.
* Excellent knowledge of regulatory requirements for in-vitro diagnostics and implementing efficient and effective studies to ensure compliance.
* Expertise and experience in the development, verification, and validation of molecular in-vitro diagnostic assays.
* Excellent documentation skills.
* Excellent data analysis, interpretation, and reporting skills.
* Experienced in the preparation and maintenance of product risk management files to meet ISO14971.
* Deep knowledge of experimental design and execution with the ability to lead and train others.
* Enthusiasm, drive, thoroughness, diligence, and a willingness to take personal responsibility to ensure that projects are successful.
* Can summarize complex scientific data to effectively communicate plans, progress, and ideas with Management, Peers, or External Audiences.
About Yourgene Health
Yourgene Health is a growing, vibrant, and exciting place to work. We are looking for committed, driven individuals to be part of our next growth journey. Our culture is described by our employees as collegiate, friendly, professional, innovative, open, and fast-paced. We have various social and well-being initiatives run by our Social Huddle that keep our sense of community alive during challenging times.