Radiometer · 12 hours ago
Research Scientist II, Applied Science in Therapeutic Oligonucleotides
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Responsibilities
Function as a scientist at the bench, under minimal supervision, reporting to a team or project lead and executing projects as part of IDT’s new Genomics Medicine Service offerings related to: off-target safety assessment for CRISPR-based editing systems, CRISPR guide RNA sequencing, and additional, custom projects associated with IDT’s Therapeutic Oligonucleotides business
Provide teamwide scientific support on all aspects of therapeutic oligonucleotides projects inclusive of lab work, project tracking and organization, data collection, data analysis, report generation, and data presentation
Plan and keep detailed experimental records in facilitating technology transfer of methods from R&D to the Gen Meds Services team; gain expertise in technologies to support further feasibility, development and validation of assays as well as propose ideas for broader use and application
Lend subject matter expertise to customer-specific oligo assessment of quality, performance, safety, etc. in cell-based, biochemical or analytical assays; assist in the definition of technical and experimental work plans related to on-going efforts to advance customer projects while supporting customer progress towards cGMP oligonucleotide synthesis
Qualification
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Required
Bachelor’s degree (in Biology, Genetics, Chemistry or a related life sciences field) with three or more years relevant lab experience OR a Master’s degree (in Biology, Genetics, Chemistry or a related life sciences field) with one or more years relevant lab experience
Demonstrated experience and technical background in CRISPR and Gene Editing rooted in research, development
Bachelor’s degree or master's in a scientific field (engineering, pharmacy, biology, biochemistry, biotechnology, medical technology, or similar)
At least 10 years’ combined work experience with Regulatory Affairs and 3 years' experience in a scientific field
Knowledge and experience in global IVD/MD regulations, quality standards such as ISO 13485, US FDA 21 Part 820, IVDR/MDR, design control, risk management, etc.
Regulatory experience with taking a product from development through regulatory approval in US and life cycle management, including interactions with regulatory bodies such as FDA and notified bodies
Good understanding of statistical methods and analysis
Preferred
Experience with giving both scientific and regulatory input to claims, test plans, test protocols (non-clinical and clinical)
Detailed knowledge about other technical or SME areas such as software, usability, stability, clinical, post market surveillance
Benefits
Paid time off
Medical/dental/vision insurance
401(k)
Company
Radiometer
When life takes an unexpected turn, Radiometer’s technology and solutions enable health care professionals to make informed diagnostic decisions to improve patient care.