About the Role
We are seeking an experienced Project Manager to lead the development, validation, and commercialization of Next Generation Sequencing (NGS)-based Laboratory Developed Tests (LDTs). This role will coordinate cross-functional teams spanning assay development, bioinformatics, laboratory operations, quality, regulatory, and commercial functions to successfully launch new clinical testing services.
The ideal candidate combines strong project management skills with a solid understanding of NGS technologies and molecular diagnostics, enabling them to effectively drive technical programs from concept through clinical launch.
Key Responsibilities
Program Leadership
- 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.
NGS and Technical Coordination
- Coordinate development of NGS-based clinical assays from design through launch.
- Work closely with scientists, bioinformaticians, and laboratory personnel to ensure successful execution of technical objectives.
- Understand and track key assay performance metrics, validation requirements, and operational readiness activities.
- Translate complex technical topics into clear project plans and business updates.
Validation and Clinical Launch
- Coordinate analytical and clinical validation studies.
- Ensure alignment of 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.
Quality and Regulatory Collaboration
- 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.
- Ensure compliance requirements are incorporated into project timelines and deliverables.
Commercial and Operational Readiness
- 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 ensure successful market adoption.
Qualifications
Required
- BS or MS in Molecular Biology, Genetics, Genomics, Bioinformatics, Biotechnology, Clinical Laboratory Science, or a related field.
- 5+ years of project or program management experience in molecular diagnostics, genomics, biotechnology, or clinical laboratory environments.
- Working knowledge of Next Generation Sequencing workflows, including sample preparation, sequencing, bioinformatics analysis, and clinical reporting.
- Experience leading cross-functional technical projects.
- Strong communication, organizational, and stakeholder management skills.
Preferred
- Experience launching NGS-based clinical assays or LDTs.
- Familiarity with CLIA and CAP laboratory environments.
- Experience working with Illumina, PacBio, or Oxford Nanopore platforms.
- PMP certification.
- Knowledge of bioinformatics pipelines, variant interpretation, and genomic reporting workflows.
