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One Biosciences · 2 days ago

Clinical Laboratory Director

Albany, NY

Full-time

Onsite

Lead/Staff, Director/Executive

5+ years exp

One Biosciences is a pioneering precision diagnostics company uniquely positioned to decipher tumor heterogeneity through the convergence of single-cell transcriptomics and artificial intelligence. The Laboratory Director will lead the establishment and early operation of a startup laboratory specializing in oncology testing, overseeing regulatory compliance, laboratory setup, and team management.

BiotechnologyLife ScienceTherapeutics

Responsibilities

Full responsibility for direction and technical operation of the laboratory - jointly and separately from the Owner - including adherence to NYS CLEP Clinical Laboratory Standards of Practice, whether serving on a regular part-time or full-time basis

Lead laboratory setup activities including facility readiness, equipment selection, LIS implementation, workflow design, budgeting, compliance, and staffing

Drive NYS CLEP/CLIA permitting processes and regulatory submissions

Collaborate closely with our Quality Systems Consultant to design, implement, maintain, and improve a compliant Quality Management System (QMS) suitable for the delivery of services that meet the needs of clients, patients, clinical personnel, and startup scaling

Oversee development, validation, and qualification of oncology molecular and cellular tumor marker assays, including Laboratory Developed Tests (LDTs)

Recruit and supervise a growing team of testing and non-testing personnel (technologists, supervisors, safety roles); establish personnel competency programs

Ensure compliant oversight structure for all test categories, with appropriate Assistant Directors as needs arise while maintaining compliance with NYSDOH restrictions on directorship scope

Oversee lab operations, scheduling, quality management, troubleshooting, and continuous improvement

Ensure alignment and seamless communication with the European Research & Development, and Operations, teams

Serve as the primary point of contact for regulatory authorities, auditors, institutional partners, suppliers, and the landlord during early operational phases – as needed dependent on evolving team

Lead inspection readiness and interface directly with NYSDOH CLEP during pre-opening and initial cycle - as needed dependent on evolving team

Qualification

Doctoral degreeNYSDOH CLEP Certificate of QualificationLaboratory Director experienceNext-generation sequencing (NGS)Quality Management System (QMS)Method validationAnalytical skillsISO accredited laboratory experienceLIS/LIMS experienceLeadership skillsCommunication skillsProblem-solving mindsetDetail orientedTeamwork

Required

Doctoral degree (MD, DO, DDS, PhD) w/NYSDOH CLEP accepted board certification

Active or eligible relevant NYSDOH CLEP Certificate of Qualification (CQ)

Adherent to NYSDOH CLEP Certificate of Qualification & Laboratory Director requirements and limitations

Minimum of 5 years relevant experience as a Laboratory Director or high-level laboratory leadership role in a regulated high-complexity testing environment

Demonstrated ability to build and manage high-performing technical teams

Proven track record leading clinical laboratory operations including staffing, quality management, troubleshooting, and continuous improvement

Strong leadership and communication skills, able to collaborate across multiple stakeholders

High rigor, attention to detail, and commitment to quality and compliance

Ability to manage complex projects, budgets, and timelines independently

Problem-solving mindset with a pragmatic, execution-oriented approach

Preferred

Prior success with NYSDOH CLEP submissions for LDT assays

Direct interaction with authoritative bodies (NYSDOH CLEP, CMS)

Significant role in hands-on system buildout, including method validation leadership, workflow design, and creation of initial laboratory documentation

In-depth knowledge of next-generation sequencing (NGS) techniques, methodology, instrumentation, software, supplies, data analysis, interpretation and preparation of final reports

Experience in method development, optimization and validation of high complexity test assays in a highly regulated environment

Participation in quality management system development, improvement and oversight

Experience in quality assurance and quality control procedures

Proficiency with computers, scientific equipment and software

Strong numerical, analytical, technical, problem-solving, and critical thinking skills

Detail oriented documentation and reporting skills

Strong leader and team worker

Electronic QMS experience

ISO accredited laboratory experience

LIS/LIMS experience