Job title: Product Development Team Leader (NGS/Next Generation Sequencing)

Reports to: Head of Product Development

Location: Manchester (site based role)

Contract Type: Full-time, Permanent

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. The group works 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, precision medicine and infectious diseases. The Group'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 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.

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 and NIPT and high throughput Covid testing service.

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 nay social and well-being initiatives run by our Social Huddle that keep our sense of community alive during challenging times that the pandemic has thrown our way. 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.

Description of role:

Yourgene Health, part of Novacyt Group are recruiting for a Product Development Team Leader focused on our Next Generation Sequencing (NGS) products and services. The Product Development Team Leader is responsible for leading teams involved in assay design and development and validation including system integration, of in vitro diagnostic products on next generation sequencing technologies. The post holder will design and develop both research use only (RUO) and CEIVD regulated products, taking the ideas from ideation through to product launch.

Overall responsibility:

An expert in Next Generation Sequencing (NGS) Technologies who can provide scientific expertise, people leadership and technical leadership during the product development cycle. Ensures team people and skill development along with resource planning is effective and aligned with priorities set out by R&D management. Works with project managers to ensure that the teams work is well planned and executed to a high quality in a timely fashion. Drives the shaping of Product Development strategy, particularly for the development of new molecular diagnostic products on NGS platforms and in the assessment of new sequencing technologies. Works with the Regulatory Affairs in the preparation of regulatory submissions to key territories (e.g. IVDR) for new products. Works with external solutions providers as well as internal bioinformatics and software development teams to ensure the best analysis solutions and reporting pipelines are available for our customers using the products.

Key areas of responsibility:

• Team leadership and people management, as well as identifying strategic and tactical improvements to function
• Effective short- and long-term resource planning, aligned against priorities and team member's skills
• Provides scientific expertise and technical leadership on all NGS projects

• Project planning and reporting in collaboration with Project Managers;
  • Ensures project planning for work-packages within own area is performed effectively
  • Contribute to overall project planning while factoring in system level thinking
  • Ensuring verification and validation activities are planned and executed to ensure relevant regulatory requirements are met
  • Working with Regulatory Affairs in the preparation of Technical documentation to ensure successful regulatory submissions
  • Ensure project planning of team activities are accurate and detailed, capturing Assay development and system integration actions in full

• Deliver optimised assays and workflows that are ready for successful Product Transfer to operations and tech support.
• Own and optimise System Integration processes, taking the lead on system integration activities when products involve two or more interacting components

• Lead and participate in activities requiring cross functional collaboration
• Work collaboratively with other Team Leaders to ensure overall process SOPs, process flows, standardized plans & reports enable fully integrated and seamless product development

• Supporting Innovation, Automation, bioinformatics, software development and Design Transfer where required
• Ensure planning and reporting of studies, work-packages and other activities is accurate and detailed
  • Efficient and effective documentation
  • Data generation, integrity and organized data management
  • Provide accurate and concise data interpretation, factoring in systems-level thinking
  • Meeting regulatory or other requirements
• Own and optimise root cause analysis (RCA) processes for the resolution of technical issues within product development. Provide training and support, enabling consistency of approach across investigations
• Collaborate in external relationships, including through for example, grant applications, KOLs and other partners
• Supports the identification of commercially and technically useful solutions for development
• Ensure own work and that of junior staff is performed in line with company goals
• Support and provide guidance and mentorship 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 10+ years of relevant experience
• Previous supervisory or line management experience
• Must have NGS experience preferably across a variety of short read and long read platforms
• Ability to work with and analyse NGS data independently and in collaboration with bioinformaticians.
• Able to manage a team of scientist and technicians, motivate as well as providing leadership and guidance
• Expertise and experience in the development, verification and validation of molecular diagnostic assays in adherence with CE marking and/or design control regulations
• Interest and experience in one of the product areas: Reproductive Health, Oncology, Pharmacogenomics, Precision Medicine.
• Experience with the development and validation of NGS technologies
• Excellent grasp of experimental design and execution and able to lead and train others

• Understanding and consideration that changes to one component may impact the entire system ("system level thinking")
• 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
• Able to assimilate knowledge from technically detailed scientific sources
• Can summarize complex scientific data in written form to effectively communicate plans, progress and ideas with Management, Peers or External Audiences
• Experience with Design of Experiment
• Good IT skills, experience of using Microsoft Office suite, JMP, R, a range of bioinformatics software packages and project management tools such as Wrike preferred.

Closing Date:

Sunday 1st December, 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.