V&V Scientist (Verification and Validation)
NuProbe USA is hiring a V&V Scientist for its Houston (TX) location. NuProbe USA is a startup devoted to the development of affordable, accurate, and non-invasive DNA diagnostic assays for cancer and other diseases.
PRIMARY PURPOSE OF POSITION
The successful candidate will contribute to the development of Next Generation Sequencing (NGS) panels for detecting rare oncogenic mutations. Work is focused on the development of verification and validation (V&V) activities for multiple systems comprised of assays, reagents, consumables, instruments, and software. The role requires strong leadership and detail-focused skillset to design, plan, and execute tests of products exiting development and to further support and improve products.
Essential Job Duties and Responsibilities:
Essential responsibilities and duties include, but are not limited to the following:
- Act as the Technical lead on studies in support of the integration, verification, and validation of automated NGS assays used in clinical laboratory products in a regulated environment
- Collaborate closely with other assay, automation, software, and operations team members to integrate and functionalize novel complex automated assays
- Drive development efforts to optimize assay performance, improve laboratory processes, and ensure production robustness
- Conduct troubleshooting investigations and related experimentation to address acute or systematic issues with implemented systems
- Collaborate closely with biostatistics and bioinformatics functions to develop robust study designs and comprehensive analyses
- Work with Quality and Regulatory team members to ensure studies fulfill necessary guidelines and regulations (CAP/CLIA/FDA)
- Develop experimental plans that support PMA study objectives
- Execute laboratory experiments in collaboration with more junior technical staff to generate high quality data by following best practices of assay and instrument operations
- Perform data analysis and document study outcomes and conclusions
- Summarize, present and document study outcomes to key stakeholders.
- Support training of junior Research Associates
Job Qualifications and Education:
- PhD degree in Molecular Biology, Genetics, Cancer Genomics, or relevant fields with 3+ years of postdoctoral or industry experience.
- Strong hands-on laboratory experience and in-depth knowledge of Illumina NGS workflows including nucleic acid extraction, library preparation, target enrichment, and sequencing.
- Hands-on experience with automated laboratory instrumentation such as liquid handlers.
- Experience with the development, optimization, and troubleshooting of NGS assay protocols on automated systems.
- Experience with the development and implementation of clinical laboratory tests regulated environments is a plus.
- Experience with design control and change control.
- Experienced with standard nucleic acid analytical techniques (e.g, qPCR, Nanodrop, Fragment Analyzer, ddPCR).
- Experience with statistical programming or software.
- Experience with Design of Experiment (DOE) a plus
- Attention to detail, safety, good laboratory practice, and good documentation practice
- Strong verbal and written communication skills and willingness to collaborate cross-functionally in a fast-paced and dynamic environment.
- Varied sitting, standing, walking
- Ability to lift and/or carry up to 50 lbs
- Company benefits, (medical, dental, vision, PTO, 401k and more)
- Professional growth: We believe in people, and we foster professional growth.
- Starting compensation will be based on experience.
NuProbe is willing to sponsor H1-b work visa for the successful candidate
This job description describes the major responsibilities of the job. It does not include all aspects of the position, such as the potential additional duties assigned by management, and the requirement for flexibility in assisting others for the company’s overall benefit.
About NuProbe USA:
NuProbe is a genomics company with proprietary technology to reduce the cost and improve the sensitivity of NGS by 100-fold. NuProbe's technologies have been featured in journals such as Nature Biomedical Engineering, Nature Chemistry, Cancer Discovery, and Nature Communications, in collaboration with collaborators from MD Anderson, Baylor College of Medicine, Thermo Fisher, Oxford Nanopore, and Microsoft Research. To date, NuProbe has raised more than $60M, and its US office based in Houston, TX has over 50 full-time employees. NuProbe's senior management team includes industry veterans from Adaptive Biotechnologies, Thermo Fisher, Nanostring, Roche, and Allergan.