Senior IVD Development Scientist
Biotechnology Clinical Life Sciences Pharmaceuticals
A very exciting opening for a Senior IVD Development Scientist has become available at a growing life sciences organisation, with R&D facilities in North East England
As Senior IVD Development Scientist you will to lead the design, implementation, management, and improvement of Next Generation Sequencing (NGS) systems to support research, product development and diagnostic testing. The Senior IVD Development Scientist is a cross-functional role and deliverables are a critical input to core proprietary technology and product pipelines. You will be commercially minded and product-focused, innovative, and collaborative with a proven track record of success from conceptualization through implementation.
• Evaluate and advise management on requirements to meet the needs of the internal stakeholders, implement the chosen system and end to end workflows to support those requirements, and manage and complete project work according to expected timelines and deliverables.
• Complete initial discovery and assay development in support of the pipeline of IVD products to establish foundational Scientific Validity and support initiation of product feasibility and transfer activities.
• Work on a cross-functional team providing technical advice and support during feasibility, development, verification, and validation of each product in compliance with ISO 13485 and IVDR, as well as analytical and clinical validation in compliance with ISO 15189.
• Develop and implement NGS data analysis processes and documentation standards for research, product development and diagnostic applications.
• Provide written technical reports, documentation, and communications of activities to support patent applications, scientific publications, design history files, internal and external corporate communications for each product as assigned.
EDUCATION & EXPERIENCE
• Ph.D. degree, in Molecular Biology or related major
• Experience in the development and optimization of regulated IVD assays
• Experience with successful IVD submissions (CE, PMA, 510(k), etc.). Experience with IVDR and
• Demonstrated mastery of NGS including DNA/RNA sequencing library preparation and quantification, assay design and optimization, data analysis.
• Extensive hands-on experience in molecular biology and cell biology techniques (DNA/RNA extraction, PCR, qPCR, ddPCR
• Strong technical writing skills
• Exceptional organizational and planning skills
• Excellent troubleshooting and multi-tasking skills, attention to detail and ability to work independently and collaboratively are required.
DESIREABLE SKILLS AND EXPERIENCE:
• Background in bioinformatics and knowledge of bioinformatics tools/databases (GATK, NCBI, UCSC, Ensembl)
• Experience in Oncology Research or Assay Development