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Salisbury , North Carolina
Posted: 11-Feb-26
Location: Albany, New York
Type: Full Time
Categories:
Sector:
Preferred Education:
Additional Information:
Internal Number: OBSNY_LD
SUMMARY:
As we scale our operations globally and expand our partnerships from Europe to the US, the Laboratory Director will lead the establishment and early operation of a startup laboratory specializing in testing within the New York State Department of Health (NYSDOH), Wadsworth Center, Clinical Laboratory Evaluation Program (CLEP); Oncology - Molecular and Cellular Tumor Marker category. This role includes overall leadership, administration, and technical oversight responsibilities for laboratory build-out, regulatory permitting, workflow design, personnel hiring, quality systems, and implementation of compliant translational research and clinical testing. The Director must meet NYSDOH CLEP Certificate of Qualification & Laboratory Director requirements and limitations; and in the absence of an Assistant Director, must hold an active NYSDOH Certificate of Qualification (CQ) for the testing category. This is a highly strategic role with significant autonomy and impact working with Executive Management and our clients - including physicians, academic partners and pharma.
PRINCIPAL DUTIES/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 Owner and 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.
SUPERVISION/AUTHORITY EXERCISED:
- Direct supervision of early-stage laboratory team;
- Authority over hiring, training, and growth of the laboratory team;
- Oversight of Assistant Directors, consultants, and temporary scientific support.
REPORTS TO:
- Executive Leadership Team
SUPERVISION RECEIVED:
- Broad strategic guidance from Executive Leadership with high degree of autonomy;
- Regulatory oversight from Authoritative Bodies, including NYSDOH CLEP.
QUALIFICATIONS/TRAINING/EXPERIENCE/SKILLS - Required:
- Doctoral degree (MD, DO, 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;
- First-hand, in practice, experience in next-generation sequencing (NGS) techniques, methodology, instrumentation, software, supplies, data analysis, interpretation and preparation of final reports;
- Demonstrated ability to build and manage high-performing technical teams;
- Proven track record leading translational research and 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.
QUALIFICATIONS/TRAINING/EXPERIENCE/SKILLS - 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;
- 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.
WORKING CONDITIONS:
- Extended on-site presence required during build-out and launch phases;
- Rapidly evolving workflows and operational demands;
- Occasional extended hours during validation or inspection preparation;
- Moderate noise of laboratory environment with multiple instruments running simultaneously;
- Standing, walking, sitting, stooping, reaching, speaking, hearing, lifting (<35 pounds);
- Ability to see in the normal visual range with or without correction; vision sufficient to read computer screens and printed documents;
- Ability to hear in the normal audio range with or without correction;
- Mechanical hazards: mechanical parts, fumes, airborne particles, toxic or caustic chemicals;
- Chemical hazards: toxins, corrosives, flammables, reactives, irritants;
- Biological hazards: potentially infectious material or biological hazard such as a microorganism (e.g. bacteria, viruses, fungi) or blood borne pathogen during handling of human-derived laboratory samples.
All position requirements listed indicate the minimum level of knowledge, skills and/or ability deemed necessary to perform the job proficiently. This job description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Employees will be required to perform any other job-related instructions given by their manager. Where feasible, reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential job functions. This job description will be reviewed annually and updated as often as necessary.