Lead Product Development Manager

2 weeks ago

Manchester, United Kingdom Yourgene Health Full time

Product Development Team Leader (NGS/Next Generation Sequencing) Reports to: Head of Product Development
Contract Type: Full-time, Permanent
Salary & Benefits: Competitive Salary + Benefits Package

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.

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. 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. 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. 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.

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
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
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
Supports the identification of commercially and technically useful solutions for development
Previous supervisory or line management experience
Ability to work with and analyse NGS data independently and in collaboration with bioinformaticians.
Expertise and experience in the development, verification and validation of molecular diagnostic assays in adherence with CE marking and/or design control regulations
Experience with the development and validation of NGS technologies
Enthusiasm, drive, thoroughness, diligence and a willingness to take personal responsibility to ensure that projects are successful
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
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.

Sunday 15th December, 2024

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

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