DxLab Inc. (DxLab)
DxLab Inc. (DxLab) is a venture-backed biotech startup, spun out of MIT and Harvard, developing and commercializing next-generation point-of-care (POC) diagnostics systems for rapid and low-cost detection of various diseases and health conditions. Combining proprietary platform technology with novel target detection and signal processing methods, we are advancing a pipeline of rapid POC tests for different pathogens and biomarkers.
We are seeking a highly motivated and skilled scientist to lead the development of our in vitro diagnostics (IVD) assays, from the feasibility stage to clinical studies to regulatory submissions/approvals. The Principal Scientist will be in charge of designing and optimizing new assay formulations, primers, and reaction conditions. The Principal Scientist will also support external CRO/CMO management, which includes communicating with the project managers at CRO/CMOs to review data, plan future studies/manufacturing, and optimize their processes to fit our needs. This position offers an opportunity to work broadly across various functions at DxLab that include clinical studies, quality management/quality assurance, regulatory submissions, manufacturing, and business development.
- Develop and optimize new assays for target oligonucleotide detection to support
the development of new IVD tests
- Evaluate performance of new assays and IVD tests using key performance metrics
- Lead in silico analyses for inclusivity and cross-reactivity assessment
- Supervise the work of junior scientists and research associates
- Manage external CRO/CMOs to carry out new studies, schedule production, procure critical components, and complete QC activities
- Support grant applications, clinical studies, and regulatory submission
- Develop inspection and QC plans and criteria for key reagents and processes
- Prepare and deliver scientific presentations for internal meetings
- Ph.D. in molecular biology, biological engineering, chemical engineering, or other related science/engineering field
- Extensive hands-on experience with PCR and/or LAMP assays; experience with molecular diagnostics assay development and/or manufacturing is a plus
- Expertise in genomic sequence analysis; experience with primer design is highly preferred
- Experience with grant writing is a plus
- Strong interpersonal and communication (verbal and writing) skills
- Time management skills and ability to meet tight deadlines
DxLab is an equal opportunity employer and values different experiences and ways of thinking.
To apply for this job please visit www.dxlab.bio.