Description

OraTek Diagnostics | Houston area, Texas | Full-time, on-site
Compensation: $125,000 annual salary plus validation milestone bonuses

Build the science behind a new generation of oral fluid testing

OraTek Diagnostics develops oral fluid collection devices, reagents and software for law enforcement, employers and clinics. We're bringing method development in-house and hiring a hands-on scientist to build and lead our science department.

You'll take oral fluid tests from the first experiment through validation and routine patient testing. Your initial focus will be our oral fluid toxicology panel on SCIEX LC-MS/MS, including the performance of our proprietary collection devices and reagents. You'll also lead development of proprietary oral fluid assays in our pipeline.

This role reports to the CEO and works closely with the lab's CLIA Laboratory Director. It offers the opportunity to shape scientific priorities, solve practical analytical problems and grow a team.

What you'll do

• Develop and validate oral fluid toxicology methods on SCIEX triple-quadrupole LC-MS/MS, from sample preparation through confirmation.
• Investigate collection-device recovery, specimen stability, shipping conditions, matrix effects, interferences and carryover.
• Write validation plans, reports and SOPs that meet CLIA and accreditation requirements, and take methods through Laboratory Director approval.
• Run samples, troubleshoot instruments and methods, and review data as testing volume grows.
• Lead feasibility and validation studies for proprietary oral fluid assays in our pipeline.
• Coordinate studies with partner and academic laboratories when additional instrumentation or expertise is needed.
• Work with the product team to improve collection devices, stabilizers and reagents based on experimental results.
• Hire and train the science team as the department grows.

What we offer

• $125,000 annual base salary.
• Bonuses tied to defined validation milestones.
• The opportunity to build a science department around proprietary technology.
• Direct collaboration with company leadership and a product team bringing your work into practice.

How to apply

Submit your résumé and a short note describing a method you personally developed and validated: the analytes, the sample matrix, your role and the hardest technical problem you solved.

Finalists will sign a nondisclosure agreement before discussing our full test pipeline.

OraTek Diagnostics is an equal opportunity employer.

Requirements

What you'll bring

• An M.S. or Ph.D. in chemistry, toxicology, clinical chemistry, pharmaceutical sciences or a related field.
• At least five years of experience in a CLIA-certified clinical laboratory or forensic toxicology laboratory.
• Hands-on LC-MS/MS method development and validation, including at least one method taken into routine patient testing.
• Working knowledge of CLIA validation requirements and CAP or COLA accreditation.
• Comfort working at the bench in a small, growing laboratory.
• Strong experimental judgment, clear documentation and the ability to turn scientific findings into practical next steps.

Helpful additional experience

• Oral fluid testing, collection-device recovery and confirmation methods.
• SCIEX instrumentation and challenging sample-preparation or stability problems.
• Bringing new tests online or building a laboratory science team.
• Immunoassay development, ICP-MS, reagent formulation or freeze-dried reagents.
• Board certification in clinical chemistry or toxicology.

Qualification to serve as a CLIA Laboratory Director is a plus. For a suitably qualified candidate, the role may include that responsibility.