GT Molecular · 22 hours ago
Head of Testing and Production - Biotech
Fort Collins, CO
Full-time
Onsite
Director/Executive
$160K/yr - $220K/yr
8+ years expGT Molecular is a fast-growing biotechnology company and Stanford University spin-out headquartered in Fort Collins, Colorado. The role involves leading and scaling day-to-day operations across manufacturing, laboratory services, supply chain, quality, and facilities to support the rapid growth of PCR kit production and digital PCR testing services.
BiotechnologyGeneticsMedical
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
Qualification
Required
8–12+ years of progressive operations leadership in life sciences, ideally in molecular diagnostics, genomics, PCR/NGS manufacturing, clinical/reference labs, or biotech services (experience scaling operations during rapid growth a plus)
Leadership of high-throughput core facilities (e.g., NGS, mass spectrometry, proteomics, or molecular diagnostics cores) strongly preferred, 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
Preferred
Experience scaling operations during rapid growth
Hands-on experience with NGS, PCR multiplex assays, proprietary enzyme/chemistry platforms, pathogen/small molecule detection, technology transfer, and LIMS implementation
Benefits
Meaningful equity
Performance-based bonus potential
Comprehensive benefits including health, dental, vision, 401(k) with match
Company
GT Molecular
GT Molecular specializes in the development of molecular genetics, assay technology, and clinical medicine.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Christopher McKee
Co-Founder and CEO
Recent News
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2024-11-04
2024-04-14
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