Validation Scientist

4 weeks ago

Manchester, United Kingdom Yourgene Health Full time

Job title: Validation Scientist II (IVDR Validation & Verification)

Reports to: Validation Team Leader

Location: Manchester Science Park

Contract Type: Full-time, 12 months FTC (maternity cover)

Salary & Benefits: Competitive Salary + Benefits Package


About Yourgene Health:

Yourgene Health is a leading integrated technologies and services business, enabling the delivery of genomic medicine. Yourgene work in partnership with global leaders in DNA technology to advance diagnostic science.


Yourgene primarily develops, manufactures, and commercialises simple and accurate molecular diagnostic solutions, for reproductive health and precision medicine. Yourgene's 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.


Yourgene has a range of innovative DNA Size Selection instruments, powered by Ranger® Technology, ideal for cell-free DNA applications in NIPT, oncology including liquid biopsy, long fragment recovery and gene synthesis applications.


Yourgene also has a global laboratory service network equipped to be a full life-cycle partner for clinical, research and pharmaceutical organisations to support partners at the preclinical, clinical, and post market stage to develop, manufacture, obtain regulatory approval and commercialise new products and services. In addition, Yourgene offers an NIPT testing service in the Manchester laboratory.


Yourgene Health is headquartered in Manchester, UK with facilities in Taipei, Singapore, the US and Canada.


Our Culture:

Yourgene 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 employee's as collegiate, friendly, professional, innovative, open and fast paced. We have plenty of social and well-being initiatives run by our Nova Social & Charity Huddle that keep our sense of community alive and allow us to be part of charity fundraisers. At Yourgene, we focus on putting values led programmes in place to ensure that we can attract, retain and develop our people. We want our people to have a career with Yourgene and we ensure that they are recognised and rewarded for their achievements and commitment, everyone plays a critical role in our growth journey.


About the role:

We are looking to recruit a Validation Scientist II on a 12 months fixed-term contract to cover maternity leave. The successful candidates will report to the Validation Team Leader and will be responsible for the design, development, verification and validation of in vitro diagnostic products and services.


Key areas of responsibility:

  • Provides scientific expertise and input into experiments through to project work-packages
  • Lead planning, execution and reporting of defined project experiments and work-packages
  • Work collaboratively with other scientists to create products and processes which meet the user needs of our customers
  • Support cross functional collaboration, which may also include leading projects
  • Create, maintain and improve of laboratory SOPs, as well as systems and process SOPs
  • Design and execute effective and efficient studies involving;
  • o Accurate and timely documentation
  • o Developing and implementing protocols to show that tests meet acceptance criteria
  • o Processing clinical samples to demonstrate clinical validity
  • o Data generation, ensuring integrity and organized data management
  • o Provide accurate and independent data interpretation, building experience of systems-level thinking
  • o Determining test parameters, such as output specifications
  • o Meeting regulatory or other requirements
  • Lead troubleshooting activities when technical issues arise
  • Team specific responsibilities:
  • o Validation: Delivery of validated tests and systems for products and services
  • Participate in activities outside of own team, such as Innovation, Assay Development, Automation, and Design Transfer, where required
  • Participation in Risk Management activities
  • Performance of laboratory maintenance tasks such as lab maintenance, stock monitoring, goods in receiving and cleaning
  • Ensure own work meets regulatory & quality requirements (including compliance to SOPs, documentation using lab books, study plans, study reports and integrity of data)
  • Support and provide guidance to junior staff


Qualifications, Skills and Abilities

  • Degree or further degree (or equivalent) in a life science such as molecular biology, biochemistry or genetics
  • Typically 5+ years of relevant experience
  • Experience in the development, verification and validation of molecular diagnostic assays in adherence with CE marking and/or design control regulations
  • Capable of analysing data and providing interpretation.
  • Hands on experience with at least two molecular biology-based assays and techniques e.g. Next Generation sequencing and/or PCR
  • Capable of independently performing experimental design and execution
  • Enthusiasm, drive, thoroughness, diligence and a willingness to take personal responsibility to ensure that projects are successful
  • Good organisational skills and thrives on working to tight timelines
  • Can summarize scientific data in written form to effectively communicate plans, progress and ideas with Management, Peers or External Audiences
  • Good IT skills, including Microsoft Office suite


Closing Date:

Sunday 19th May, 2024


Yourgene Health is committed to encouraging equality, diversity and inclusion among our workforce. The aim is 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.

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