The Company

BioTracers is a recent spin-out of Trace-Ability. This candidate will be responsible (among other things) for Technology Transfer and will initially have roles with both companies.

Sepsis is the most expensive condition treated in US hospitals at over $50B per year. A core challenge is that the current standard of care requires 2-4 days to identify infection and treatment. In that time, hospitals provide empiric therapy which may not be effective, thus increasing the morbidity and mortality associated with sepsis.

In the in-vitro diagnostics market the early detection of sepsis has been one of the most challenging problems to solve. For years companies have attempted various host-immune biomarkers (proteins, mRNA) to determine sepsis risk/probability, but none of these identifies actual infection. BioTracers aims to deliver a new paradigm in sepsis detection and treatment.

Our core technology is a novel biomarker which provides universal bacterial detection and identification directly from whole blood in ~1 hour. Our product roadmap includes leveraging this same biomarker to build an ultra-rapid antibiotic sensitivity test to determine targeted antibiotics for the infection in ~4 hours direct from whole blood.

BioTracers is developing these breakthrough solutions for near-patient use in the hospital Emergency Department to deliver unmatched clinical utility and cost savings. The company is a spin-out of Trace-Ability, established in 2013. We are in the process of completing feasibility studies and raising seed funding. This is an opportunity to join the company at the earliest stages and lead the effort to deliver a significant inflection point in company value.

The Job

As the Technical Lead of Sepsis Diagnostics, you will lead all scientific, technical, and operational activities required to design, develop, and validate the BioTracers RT-PCR-based biomarker assay. The initial focus is designing and completing feasibility studies to characterize biomarker performance and de-risk the technology. This role will be responsible for designing the experimental plan and leading its execution. The Technical Lead of Sepsis Diagnostics will work closely with VP of R&D, CEO, and CPO of BioTracers as we progress through fund raising and value creation.

Essential Duties & Responsibilities

· Define the scientific strategy and technical roadmap for assay development, including target selection, primer/probe design, panel composition, and analytical performance requirements.

· Oversee feasibility, and optimization efforts for biomarker qPCR assay.

· Lead assay architecture decisions related to nucleic-acid extraction, sample preparation workflows, inhibitor mitigation, internal controls and eventually system integration.

· Drive development of a contrived test system, reference methods, comparator assays, and external quality test material.

· Present R&D progress, risk mitigation and project plan updates to executive leadership and investors.

· Contribute to company strategy by articulating technical risk, product differentiation, new product concepts and technology/platform enhancements.

· Help with future Product Development Process deliverables, including but not limited to: Product Requirements Document (PRD), Risk Assessment (RA), Design and Development Plan (DDP) and overall V&V and 510(k) strategy.

Key Qualifications and Required Experience

· PhD or MS in Molecular Biology, Microbiology, Biochemistry, Biomedical Engineering, or related discipline.

· 10+ years of assay development experience with a minimum of 5 years leading teams in a regulated IVD environment

· Demonstrated track record of developing PCR-based IVD assays from concept through completion with preference of FDA 510(k) submission experience.

· Infectious disease expertise preferred.

Skills – Technical

· Proven ability to lead an R&D team and develop new products.

· Expertise in qPCR assay design and optimization, clinical microbiology, bioinformatics, sample preparation and analytical characterization.

· Deep knowledge base of clinical microbiology technology and workflow, bacterial pathogens, and experience developing novel diagnostics.

· Familiarity with sepsis/infectious disease assays, bacterial culture and AST strongly preferred.

· Preferred background in design control process, risk management, traceability and formal product development documentation required for FDA clearance and ISO audits.

· Preferred hands-on experience in assay development.

Skills – General

· Proven ability to lead an R&D team and develop new products

· Strong program-management capabilities: timeline creation, critical-path analysis, resource planning, and cross-functional alignment.

· Strategic mindset with a bias toward execution, disciplined decision-making, and risk-balanced innovation.

· Self-starter with the ability to take ownership over processes and meet company deadlines.

· Proven and effective interpersonal communication skills.

Company location: San Diego or Los Angeles area

Job Type: Fractional part-time role evolving to Full-time

Applicants must have U.S. employment authorization. The company will not sponsor applicants for U.S. work visas.

Pay: $120,000.00 - $180,000.00 per year

Education:

Doctorate (Required)

Experience:

assay development: 10 years (Required)
team ledership: 5 years (Required)
Microbiology: 5 years (Required)
Infectious disease diagnostics development: 2 years (Preferred)

Work Location: Hybrid remote in Carlsbad, CA 92011

BioTracers, Inc. / Trace-Ability, Inc. jobs

Technical Lead - Sepsis Diagnostics

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