NGS Assay Development Lead / Laboratory Super

Envita Medical Centers LLC•Scottsdale, AZ

4d•$115,000 - $145,000•Onsite

About The Position

Genetic First seeks a technically exceptional, hands-on assay developer to build and improve NGS/RNA laboratory-developed test (LDT) workflows and contribute to bioinformatics integration. This is a bench-first scientific leadership role combining direct technical ownership with collaboration, staff training, and laboratory quality. The position is onsite in Scottsdale, Arizona, full-time, Monday through Friday, 9:00 a.m. to 5:00 p.m., with a stated salary range of $115,000–$145,000. The role is responsible for developing and optimizing specimen-to-result NGS and RNA workflows, planning and executing clinical-grade assay validation, contributing technically to analytical pipelines, establishing quality-control and reproducibility practices, and building CAP/CLIA-quality documentation. The successful candidate will maintain hands-on bench ownership while transferring technical knowledge and training testing personnel, and will coordinate implementation decisions across laboratory, research, and bioinformatics teams. Performance expectations include assessing platforms, instrumentation, reagents, specimen risks, and laboratory capabilities; establishing preliminary workflows and documenting experimental progress; drafting LDT validation plans, protocols, SOPs, QC procedures, and risk assessments; contributing to pipeline implementation, testing, automation, or troubleshooting; defining and monitoring operational QC metrics; resolving deviations and technical issues; and progressing toward documented readiness for routine clinical testing only after applicable validation and approvals. The position may ultimately include CAP/CLIA high-complexity Technical Supervisor duties only if eligibility is confirmed and the candidate is formally designated.

Requirements

Demonstrated first-hand responsibility for developing or substantially modifying NGS/RNA assays and resolving complex wet-lab workflow challenges.
Personal bench-level expertise in assay development and execution.
Ability to integrate specimen-to-result workflows and contribute directly to bioinformatics pipeline implementation, troubleshooting, or analysis.
Graduate education in a relevant scientific discipline, or an appropriate combination of education and directly relevant experience.
Candidates must meet any regulatory qualifications required for formally assigned laboratory supervisory duties.
Ability to document experimental work, validation studies, QC, procedures, deviations, and corrective actions rigorously.
Ability to work collaboratively across laboratory, research, clinical, and bioinformatics teams.

Nice To Haves

Clinical laboratory assay validation experience and working knowledge of CLIA/CAP quality and documentation expectations.
Relevant experience with tumor tissue, liquid biopsy, low-input RNA, RNA quality assessment, or pathogen-detection assays.
Experience with automated sequencing, molecular profiling, and relevant laboratory platforms; equivalent assay-development experience is valued.
Coding, configuring, or testing analytical pipeline steps.

Responsibilities

Personally develop or modify NGS and RNA assays and perform extraction, quality assessment, library preparation, sequencing, troubleshooting, and optimization.
Develop end-to-end wet-lab workflows, including work involving fresh frozen tumor tissue, liquid biopsy, low-input RNA, RNA extraction and QC, and pathogen-detection workflows as appropriate to assigned assay scope.
Design and execute LDT validation studies and maintain traceable raw data, QC records, SOPs, deviations, and corrective-action documentation.
Contribute directly to bioinformatics pipeline development, implementation, automation, testing, or troubleshooting in collaboration with computational specialists.
Evaluate and optimize sequencing and molecular analysis technologies with vendor and scientific support.
Establish and monitor operational KPI baselines, including sequencing run success, assay reproducibility, validation milestone completion, corrective-action closure, efficiency, training, and cost/inventory.
Develop SOPs, QC procedures, validation records, training requirements, and a compliance gap register in coordination with laboratory leadership.
Troubleshoot workflow failures, investigate root causes, resolve deviations, and document corrective actions and effectiveness checks.
Train colleagues on implemented workflows and document observed competency in coordination with responsible laboratory leaders.
Coordinate development plans, milestones, dependencies, risks, resources, inventory, reagent costs, and cross-functional decisions.
Develop technical leadership capabilities and, when qualified and formally designated, undertake applicable high-complexity laboratory supervisory duties under laboratory director oversight.