Project Manager, NGS Clinical Diagnostics

SeqMatic LLC.•Fremont, CA

12h

About The Position

We are seeking an experienced Project Manager to lead the development, validation, and commercialization of Next Generation Sequencing (NGS)-based Laboratory Developed Tests (LDTs). The role coordinates cross-functional teams spanning assay development, bioinformatics, laboratory operations, quality, regulatory, and commercial functions to launch new clinical testing services. The ideal candidate combines strong project management skills with an understanding of NGS technologies and molecular diagnostics, driving technical programs from concept through clinical launch.

Requirements

BS or MS in Molecular Biology, Genetics, Genomics, Bioinformatics, Biotechnology, Clinical Laboratory Science, or a related field.
At least 5 years of project or program management experience in molecular diagnostics, genomics, biotechnology, or clinical laboratory environments.
Working knowledge of NGS workflows, including sample preparation, sequencing, bioinformatics analysis, and clinical reporting.
Experience leading cross-functional technical projects.
Strong communication, organizational, and stakeholder management skills.

Nice To Haves

Experience launching NGS-based clinical assays or LDTs.
Familiarity with CLIA and CAP laboratory environments.
Experience with Illumina, PacBio, or Oxford Nanopore platforms.
PMP certification.
Knowledge of bioinformatics pipelines, variant interpretation, and genomic reporting workflows.

Responsibilities

Develop and manage integrated project plans, timelines, milestones, and deliverables.
Lead cross-functional project teams and drive accountability across stakeholders.
Identify project risks, dependencies, and mitigation strategies.
Provide regular status updates to leadership and key stakeholders.
Coordinate development of NGS-based clinical assays from design through launch.
Work with scientists, bioinformaticians, and laboratory personnel to ensure technical objectives are executed successfully.
Understand and track assay performance metrics, validation requirements, and operational readiness activities.
Translate complex technical topics into clear project plans and business updates.
Coordinate analytical and clinical validation studies.
Align assay development, bioinformatics, quality, and regulatory activities.
Drive completion of documentation, SOPs, training, and launch-readiness requirements.
Support implementation of new tests into clinical laboratory operations.
Partner with Quality and Regulatory teams to support CLIA, CAP, HIPAA, and applicable state compliance requirements.
Track validation documentation, change controls, audit readiness, and quality milestones.
Incorporate compliance requirements into project timelines and deliverables.
Coordinate launch activities across operations, business development, marketing, and customer support teams.
Support laboratory capacity planning, customer onboarding, and implementation activities.
Facilitate communication between technical and commercial stakeholders to support market adoption.