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10x Genomics · 1 day ago

Sr. Project Manager, Clinical Diagnostics Development

Pleasanton, CA

Full-time

Onsite

Senior Level

$151K/yr - $204K/yr

7+ years exp

10x Genomics is committed to accelerating our understanding of biology and is seeking a Senior Project Manager for Clinical Diagnostics Development. This role will lead critical projects to establish and sustain the clinical diagnostics program, ensuring compliance with regulatory standards while managing cross-functional initiatives.

Biotechnology

H1B Sponsor Likely

Responsibilities

Support the planning and execution of technical transfer and analytical validation projects for new single-cell and spatial assays from assay development teams into the CLIA Laboratory, ensuring full traceability and documentation for verification/validation and that all regulatory requirements are met prior to go-live

Develop and maintain detailed project schedules, resource plans, risk registers and work breakdown structures in partnership with 10x internal teams

Conduct thorough risk assessments and develop comprehensive mitigation strategies for all assigned projects, particularly those impacting quality and regulatory standing

Manage change control processes, scope creep, and schedule deviations, proactively communicating potential impact to stakeholders and proposing mitigation strategies

Ensure rigorous documentation and record-keeping throughout the project life cycle

Collaborate with the quality team to drive the project plans for QMS establishment, ensuring all project documentation (e.g., facility documentation, equipment qualification, process SOPs) aligns with CLIA/CAP requirements and is audit-ready

Collaborate with the information technology team to drive project plans for LIMS and the compute infrastructure required for clinical operations

Facilitate the accreditation roadmap, scheduling and tracking deliverables required for CAP inspections, CLIA certification, and specific state approvals (e.g., New York State permit readiness)

Partner closely with Quality and Regulatory teams to ensure that project milestones incorporate necessary controls and compliance steps

Serve as the primary project communication hub, ensuring clear, consistent, and timely reporting of project status, milestones, risks, and dependencies to the project teams and executive stakeholders

Organize and lead recurring project review meetings with cross-functional teams, including Laboratory Operations, Assay Development, Clinical Bioinformatics, Quality Assurance, IT, and platform R&D teams to ensure alignment and accountability

Foster strong working relationships with technical leads and subject matter experts to accurately capture project requirements and drive decision-making

Guide 10x internal teams on project management best practices and principles

Qualification

PMP certificationProject management toolsMolecular diagnosticsNext-Generation SequencingRegulatory standardsLIMS implementationAnalytical skillsChange managementCommunication skillsOrganizational skills

Required

Advanced degree (Master's or Ph.D.) in a molecular biology, immunology, bioengineering, or related field

Minimum of 7 years of professional experience managing complex projects in a regulated molecular diagnostics or life sciences company

Experience managing projects involving molecular diagnostics or Next-Generation Sequencing (NGS) platforms

Proficiency with project management tools (e.g., Microsoft Project, SmartSheet, Jira) and collaboration platforms

PMP certification

Deep experience in project strategy

Technical familiarity with advanced molecular profiling technologies (NGS, single cell, spatial)

Strong understanding of regulated diagnostic product development (e.g., CLIA, CAP, ISO 13485 or 21 CFR Part 820) and documentation control

Experience with LIMS implementation, integration, or major upgrade projects

Preferred

Project Management Professional (PMP) certification or equivalent qualification (e.g., Lean Six Sigma)

Strong analytical skills and the ability to translate complex technical requirements into actionable project plans

Excellent written and verbal communication skills, capable of effectively interacting with scientific, technical, and executive audiences

Exceptional organizational skills, attention to detail, and a structured approach to problem-solving

Proven ability to lead and manage cross-functional teams without direct reporting authority

Proficiency in change management principles

Driven, thoughtful, and ambitious, with a high sense of ownership and urgency to build new, high-quality, and compliant capabilities

Benefits

10x’s equity grants

Comprehensive health and retirement benefit programs

Annual bonus program or sales incentive program

Company

10x Genomics

Glassdoor3.5

Cells are the basic unit of life.

Founded in 2012

Pleasanton, California, US

1001-5000 employees

http://10xgenomics.com

H1B Sponsorship

10x Genomics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (41)

2024 (40)

2023 (35)

2022 (52)

2021 (34)

2020 (16)