NGS Assay Development Lead / Laboratory Super

Envita Medical Centers LLC; Scottsdale (AZ); Presencial; USD 115.000 - 145.000; Jornada completa

Descripción de la vacante

Envita Medical Centers LLC is seeking an NGS Assay Development Lead / Laboratory Supervisor in Scottsdale, AZ. The role combines bench-level assay development with technical leadership to build and validate NGS/RNA workflows and integrate bioinformatics pipelines.

You will drive LDT validation, QC metrics, SOPs, and documentation for CAP/CLIA readiness while training staff and coordinating cross-functional teams. A graduate science degree and hands-on NGS experience are required.

Formación

• Demonstrated hand-on responsibility for developing or modifying NGS/RNA assays.
• Experience in aligning wet-lab work with bioinformatics pipelines and data interpretation.
• Knowledge of CLIA/CAP quality and documentation expectations is strongly preferred.

Responsabilidades

• Personally develop NGS/RNA assays and end-to-end wet-lab workflows.
• Build and execute LDT validation plans and essential SOPs.
• Integrate and contribute to bioinformatics pipelines and data analysis.
• Establish robust QC metrics and troubleshooting procedures.
• Lead documentation for CAP/CLIA readiness and supervision.
• Transfer knowledge and train testing personnel on implemented workflows.
• Deliver disciplined implementation with cross-functional decisions.

Conocimientos

NGS/RNA assays

Leadership

Bioinformatics

CLIA/CAP knowledge

Educación

Graduate degree in a relevant science

Herramientas

NGS platforms

Descripción del empleo

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

NGS Assay Development Lead / Laboratory Super

GeneticFirst Full Time Scottsdale, AZ, US

2 days ago Requisition ID: 1153

Salary Range: $115,000.00 To $145,000.00 Annually

NGS Assay Development Lead / Laboratory Supervisor 115-145K

PERFORMANCE-BASED PROFILE | Genetic First / Envita

The opportunity

Why this role exists

Genetic First seeks a technically exceptional, hands-on assay developer to personally build and improve NGS/RNA laboratory-developed test (LDT) workflows and contribute to bioinformatics integration. This is a bench-first scientific leadership opportunity combining direct technical ownership with collaboration, training and laboratory quality.

Business outcomes | Key Performance Objectives (KPOs)

Success will be demonstrated through measurable experimental progress, documented assay development, rigorous validation practices, effective troubleshooting and collaboration across laboratory and analytical teams.

1. Personally develop NGS/RNA assays and end-to-end wet-lab workflows

Day 30: evaluate platform, instrumentation, reagents, specimen risks, and lab capabilities; document initial gaps and a feasible assay-development strategy. Day 60: personally establish and iterate preliminary workflows from specimen preparation through sequencing and data outputs, recording performance and failure modes. Day 90: demonstrate independent experimental execution, documented optimization work, and an implementation roadmap. Six months: execute agreed development milestones; year one: reproducible and operationally dependable workflows, as defined for the role.

Evidence of success: Bench records, development notebook, workflow map, reagent/lot and control records, quantified iterations, specimen-matrix feasibility, laboratory leadership review.

2. Build clinical-grade assay validation strategy and execute validation

By day 90, personally develop an LDT validation plan, draft validation protocols, intended-use definitions, risk assessments, acceptance criteria and essential SOP/QC documents. By six months, perform and document prioritized validation experiments and address deviations. By year one, achieve the approved validation and documentation milestones required before any authorized routine clinical testing.

Evidence of success: Signed plan and protocols, assay-specific performance studies, traceability, deviations/CAPA, readiness reviews, evidence distinguishing research from clinical use.

3. Integrate and contribute technically to bioinformatics pipelines

By day 60, map data generation, analytical steps, QC gates and handoffs. By day 90, personally demonstrate substantive hands-on contribution to analytical pipeline development, implementation, automation, testing or troubleshooting, collaborating with specialized bioinformatics support as needed. By six months, make sample-to-result analysis reproducible with documented change control.

Evidence of success: Code/workflow artifacts or documented algorithm/configuration contributions, reproducibility testing, controls, versioning, pipeline error analysis and partner validation.

4. Establish rigorous QC, reproducibility and technical troubleshooting

By day 90, define key QC metrics and baselines for sequencing run success, sample quality, repeat rates, assay reproducibility and corrective-action closure. By six months, demonstrate root‑cause resolution and measurable workflow improvements. By year one, sustain approved operational KPI performance with documented exceptions.

Evidence of success: Run‑success numerator/denominator, repeat and control charts, investigative evidence, corrective actions and effectiveness checks; performance targets established from validated baselines.

5. Build CAP/CLIA-quality documentation and qualification pathway

By day 90, draft SOPs, QC procedures, validation records, training requirements and a compliance gap register in coordination with laboratory leadership. By six months, progress toward documented readiness and applicable competency requirements. Ultimately serve in the CAP/CLIA high‑complexity Technical Supervisor capacity only after the laboratory confirms eligibility, specialty/subspecialty fit and formal designation.

Evidence of success: Document approvals, audit trail, instrument records, procedures, quality system evidence, documented education/ experience and formally assigned supervisory responsibilities.

6. Transfer technical knowledge and train testing personnel

By day 90, identify skill gaps and create a competency/training plan for relevant staff. By six months, train colleagues on implemented workflows and document observed competency in coordination with responsible laboratory leaders. Preserve personal bench ownership while developing team reliability.

Evidence of success: Skills matrix, training records, observations, repeatability between operators, competency documentation.

7. Deliver disciplined implementation and cross‑functional decisions

By day 30, establish development‑plan owners, dependencies, risks and escalation paths; by day 90, issue a credible prioritized plan and progress report. At six months/year one, deliver agreed milestones while transparently managing inventory, reagent cost, technical risk and integration with research and bioinformatics.

Evidence of success: Milestone tracking, decisions, budget/inventory baselines, controlled change management, cross‑functional feedback.

30 / 60 / 90-day success milestones

Timing

Required evidence

First 30 days

Assess available sequencing and molecular analysis platforms, instruments, reagents, specimen suitability and lab capabilities; identify risks, owners and resource dependencies.

By 60 days

Establish preliminary specimen-to-analysis development workflows; demonstrate personal bench progress; develop initial pipeline interface map and QC measures.

By 90 days

Demonstrate independent technical capability, credible implementation plan, measurable experimental progress, LDT validation plan, draft SOPs, QC procedures and validation protocols.

Move from plans to execution: documented assay optimization, prioritized validation studies, reproducibility, deviation resolution and quality-system progress against approved milestones.

Year one

Dependable, well‑documented NGS program positioned for routine testing only after applicable validation/approvals; measurable KPI discipline and a foundation for subsequent assay development.

First year | definition of exceptional performance

Exceptional performance means personally delivering substantial assay‑development work, reproducible and defensible analytical performance, validated workflow milestones, meaningful technical contributions to bioinformatics integration, appropriate readiness for authorized routine testing, and a quality‑driven laboratory team.

• Personally develop/modify NGS and RNA assays and run extraction, quality assessment, library preparation, sequencing, troubleshooting and optimization.
• Work with 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, SOPs, deviation and corrective-action records.
• Contribute technically to bioinformatics pipelines, ideally by coding/configuring/testing steps; partner with computational specialists rather than delegating all analytical responsibility .
• Evaluate and optimize available sequencing and molecular analysis technologies with vendor and scientific support.
• Develop operational KPI baselines including sequencing run success, assay reproducibility, validation milestone completion, corrective‑action closure, efficiency, training and cost/inventory.
• Develop technical leadership capabilities and, where qualified and formally designated, undertake applicable high‑complexity laboratory supervisory duties under laboratory director oversight.

Experience and critical requirements

• Demonstrated first‑hand responsibility for developing or substantially modifying NGS/RNA assays and resolving complex wet‑lab workflow challenges. This position requires personal bench‑level expertise.
• Ability to integrate specimen‑to‑result workflows and contribute directly to bioinformatics pipeline implementation, troubleshooting or analysis.
• Strongly preferred: 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 is advantageous; equivalent assay development experience is valued.
• 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.

Environment and behavioral differentiators

Hands‑on builder, rigorous experimental thinker, resilient troubleshooter, meticulous documenter, comfortable in a developing laboratory, practical with limited information, collaborative across R&D and clinical teams, and patient‑first in managing the risk of unreliable laboratory results.