Inocras Inc. · 1 day ago
Clinical Development Scientist
San Diego, CA
Full-time
Onsite
Senior Level
$95K/yr - $130K/yr
5+ years expInocras Inc. is an AI-driven precision genomics company pioneering whole genome sequencing and bioinformatics for cancer diagnostics. We are seeking an experienced Clinical Development Scientist to drive assay innovation and technology evaluation within a CAP/CLIA-certified clinical laboratory, bridging traditional R&D with clinical operations.
Biotechnology
Responsibilities
Lead the end-to-end development of new molecular assays (using DNA, RNA, cfDNA, applications such as WGS, WES, methylation, single cell etc.) from concept through clinical implementation
Independently evaluate, design, and optimize experimental workflows, from sample prep, through library prep, sequencing, and data QC
Conduct feasibility studies to assess new technologies, chemistries, and methodologies
Perform systematic optimization (DOE, protocol adjustments, reagent comparisons, etc.) to achieve robust assay performance
Meet directly with vendors to evaluate new instrumentation, kits, consumables, chemistries, and automation solutions
Perform independent research comparing technologies, platforms, and method options
Coordinate procurement and testing of new equipment and/or materials, including bringing up vendor-agnostic workflows from scratch
Design validation plans in accordance with CAP/CLIA/CMS requirements (accuracy, precision, reportable range, sensitivity/specificity, analytical validity, etc.)
Execute validation studies, manage timelines, and coordinate sample sets and logistics
Analyze data rigorously and write comprehensive validation reports suitable for regulatory review and medical director approval
Draft and maintain SOPs, work instructions, and training materials
Train Clinical Laboratory Scientists (CLSs) on new assays, workflows, and equipment
Collaborate with Quality, Bioinformatics, Lab Operations, and Medical Directors to ensure smooth assay transition to production
Support troubleshooting of existing assays and contribute to continuous improvement initiatives
Qualification
Required
Experience in assay innovation and technology evaluation within a CAP/CLIA-certified clinical laboratory
Hands-on experience with nucleic acid–based assays
Ability to design assays from the ground up
Troubleshooting complex workflows
Leading feasibility, optimization, and validation studies
Lead the end-to-end development of new molecular assays (using DNA, RNA, cfDNA, applications such as WGS, WES, methylation, single cell etc.) from concept through clinical implementation
Independently evaluate, design, and optimize experimental workflows, from sample prep, through library prep, sequencing, and data QC
Conduct feasibility studies to assess new technologies, chemistries, and methodologies
Perform systematic optimization (DOE, protocol adjustments, reagent comparisons, etc.) to achieve robust assay performance
Meet directly with vendors to evaluate new instrumentation, kits, consumables, chemistries, and automation solutions
Perform independent research comparing technologies, platforms, and method options
Coordinate procurement and testing of new equipment and/or materials, including bringing up vendor-agnostic workflows from scratch
Design validation plans in accordance with CAP/CLIA/CMS requirements (accuracy, precision, reportable range, sensitivity/specificity, analytical validity, etc.)
Execute validation studies, manage timelines, and coordinate sample sets and logistics
Analyze data rigorously and write comprehensive validation reports suitable for regulatory review and medical director approval
Draft and maintain SOPs, work instructions, and training materials
Train Clinical Laboratory Scientists (CLSs) on new assays, workflows, and equipment
Collaborate with Quality, Bioinformatics, Lab Operations, and Medical Directors to ensure smooth assay transition to production
Support troubleshooting of existing assays and contribute to continuous improvement initiatives
Preferred
Master's or PhD in Molecular Biology, Genetics, Bioengineering, Biochemistry, or related field
5+ years of hands-on molecular R&D experience (industry preferred), including independent method development
Deep expertise with DNA and RNA workflows, including extraction, QC, library preparation, sequencing and/or other molecular methods
Experience with FFPE, degraded samples, and/or complex clinical matrices
Proven ability to design, optimize, and validate assays with minimal supervision
Strong scientific writing skills (validation reports, protocols, SOPs)
Familiarity with CAP/CLIA regulatory requirements for LDTs (direct experience strongly preferred)
Demonstrated ability to troubleshoot complex assay issues scientifically and systematically
Benefits
Health, Dental, Vision, and employer covered AD&D policy.
401k plan
Paid Holidays, Sick, and PTO
Company
Inocras Inc.
Inocras is a bioinformatics-led company redefining precision health through whole genome data and proprietary analytics.
11-50 employees
H1B Sponsorship
Inocras Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Early StageRecent News
2025-05-04
2025-04-02
2024-10-29
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