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.
Key Responsibilities
- 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 userformance 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
Qualifications
- 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
To apply, send a resume/CV to support@dxlab.bio or visit https://www.dxlab.bio/join-the-team .
DxLab is an equal opportunity employer and values different experiences and ways of thinkin