Head of Testing and Operations - Biotech

About GT Molecular

GT Molecular is a fast-growing biotechnology company and Stanford University spin-out headquartered in beautiful Fort Collins, Colorado. We deliver ultrasensitive multiplex digital PCR (dPCR) and qPCR assays powered by our proprietary chemistry—enabling superior sensitivity, robust multiplexing, and reliable detection at low concentrations. Our platforms support end-to-end testing services and commercial kits for oncology research, pathogen detection (SARS-CoV-2, Influenza, RSV, mpox, Polio, Measles, and more), illicit drug monitoring in wastewater, microbial source tracking, and emerging environmental testing (including PFAS/forever chemicals).

Our mission drives public health, environmental surveillance, and cancer research forward. With recent milestones like our CLIA laboratory, CDC's NWSS Multi-Pathogen Assay Development Contract, expanding environmental services, and new hires in lab management and bioinformatics, we're at a pivotal growth stage needing strong operational leadership to scale our proprietary dPCR technology across services and kits.

The Role

In this hands-on role, you will own and scale day-to-day execution across manufacturing, laboratory services, supply chain, quality, and facilities. Reporting directly to the CEO, you'll build professional operations infrastructure to support rapid growth in PCR kit production and NGS / digital PCR testing services - with a focus on high-throughput workflows, operationalizing our proprietary dPCR chemistry for consistent performance, efficiency, compliance, and scalability in a collaborative, mission-driven environment.

Key Responsibilities

• Lead PCR kit manufacturing, including scaling production of multiplex dPCR and qPCR panels incorporating our proprietary chemistry (enzymes, formulations, and reagents); manage supply chain/vendor relationships, inventory, lot-to-lot consistency, and quality to meet demand from CLIA labs, academics, municipalities, and public health partners.
• Optimize operations for microbiology and high-risk testing services, with emphasis on routine wastewater surveillance for pathogens and small molecules (e.g., illicit drugs) using our ultrasensitive dPCR platform and proprietary chemistry in CLIA/high-complexity labs; drive high-throughput workflow efficiency, capacity planning during volume surges, 24–48 hour turnaround, chain-of-custody, and biosafety (BSL-2 ) compliance.
• Drive technology transfer from R&D to Operations (including new dPCR assays and chemistry enhancements) and oversee implementation of LIMS systems to enhance throughput, data management, and process automation.
• Collaborate closely with the part-time CLIA consultant (serving as Laboratory Director) and lab teams to integrate lab ops with company-wide processes—focusing on throughput, cost control, resource allocation, and non-technical scaling during growth phases.
• Oversee quality systems and regulatory compliance (CLIA, CAP, ISO 13485, FDA EUA/IVD pathways, or similar highly regulated environments a strong plus), risk management, and continuous improvement across manufacturing and services, ensuring proprietary chemistry integrity and assay performance.
• Drive cross-functional alignment (e.g., quality, facilities, IT, automation, project management) with R&D, sales, bioinformatics, and finance to support revenue growth, forecast needs, and enable new service lines (e.g., deep sequencing and PFAS/environmental testing).
• Build and mentor a growing operations team (production, lab ops, logistics, quality) with experience scaling high-throughput operations preferred.
• Implement tools to eliminate bottlenecks, drive cost/efficiency gains, and manage budgets effectively.

Qualifications

• 8–12 years of progressive operations leadership in life sciences, ideally in molecular diagnostics, genomics, PCR/NGS manufacturing, clinical/reference labs, or biotech services.
• Leadership of high-throughput core facilities (e.g., NGS, mass spectrometry, proteomics, or molecular diagnostics cores) is a plus, with hands-on experience NGS, PCR multiplex assays, proprietary enzyme/chemistry platforms, pathogen/small molecule detection, technology transfer, and LIMS implementation also valued.
• At least a Bachelor's degree in a relevant field (Biological sciences, Chemistry); PhD, HCLD certification, or MBA preferred.
• Direct experience with validating and introducing molecular assays into a production environment.
• Strong knowledge of regulated workflows and quality/regulatory standards (CLIA/CAP, ISO 15189/13485, FDA oversight, or multi-site lab management a plus).
• Proven ability to deliver fast turnaround in service labs and scale production without compromising quality.
• Excellent leadership, communication, and collaboration skills; comfortable working with scientific founders/CEOs and empowering technical teams.
• Fort Collins/Colorado-based or willing to relocate; excited about public health impact and the collaborative foothills lifestyle.

What We Offer

• Base salary range: $160,000–$220,000 annually, depending on experience and qualifications
• Meaningful equity (ownership in a growing company), performance-based bonus potential, and comprehensive benefits including health, dental, vision, 401(k) with match
• High-impact role with direct CEO access during a key growth phase
• Collaborative culture in scenic Fort Collins—outdoor access, innovative biotech community

How to Apply Send your resume and a brief note on why you're passionate about scaling molecular diagnostics and wastewater/environmental testing operations to careers@gtmolecular.com (or apply via LinkedIn). Please include "Head of Operations" in the subject line. We encourage diverse applicants.

GT Molecular is an equal opportunity employer. We look forward to hearing from you!