Job Title: Laboratory Director - Genetic Diagnostics & Innovation

Compensation: $120,000.00 - 170,000.00 (Dependent on Experience)

Job Type: Full Time with Benefits (Medical, Life, Dental, Vision, 401k, and PTO)

About Us:

We are a forward-thinking healthcare organization committed to providing exceptional patient care and driving innovation. We are excited to announce the launch of a new, state-of-the-art genetic diagnostics laboratory focused on delivering personalized insights for oncology and infectious disease patients. This strategic initiative will allow us to enhance our research and development capabilities and offer cutting-edge, targeted diagnostic solutions. We are seeking a dynamic and experienced leader to establish, oversee, and grow this critical new division.

Position Summary:

We are seeking a highly motivated and accomplished Laboratory Director to lead the establishment and ongoing operations of our new genetic diagnostics laboratory. This pivotal role will be responsible for the overall strategic direction, regulatory compliance, and scientific integrity of the laboratory. The ideal candidate will possess a strong background in molecular diagnostics, particularly in RNA and DNA sequencing, and have a proven track record of successfully navigating CLIA audits for high-complexity laboratories. This is an exceptional opportunity for a visionary leader to build a world-class laboratory, foster innovation, and make a significant impact on patient care.

Responsibilities:

Leadership and Operational Oversight: Provide strategic leadership and direction for the genetic diagnostics laboratory, overseeing all day-to-day operations, including sample processing (extraction, quantitation), RNA and DNA sequencing, microscopy (including dark field), and data analysis.
Regulatory Compliance: Ensure full compliance with all applicable federal, state, and local regulations, including CLIA, CAP (if applicable), and other relevant standards. Lead and manage all internal and external audits and inspections.
Quality Assurance and Quality Control: Establish and maintain robust quality assurance and quality control programs, ensuring the accuracy, reliability, and validity of all laboratory testing. Develop and implement Standard Operating Procedures (SOPs) and ensure adherence.
Team Building and Management: Recruit, train, and manage a high-performing team of laboratory technologists, scientists, and support staff. Foster a collaborative and innovative work environment.
Bioinformatics Pipeline Development: Collaborate with bioinformatics professionals to coordinate the development, validation, and implementation of bioinformatics pipelines for the analysis of genomic data.
Research and Development: Drive innovation within the laboratory, identifying and implementing new technologies, methodologies, and assays to enhance diagnostic capabilities and support research initiatives.
Material and Vendor Management: Oversee the procurement, inventory management, and quality control of all laboratory materials and reagents. Manage relationships with vendors.
Stakeholder Collaboration: Effectively communicate with physicians, researchers, and other stakeholders to ensure seamless integration of laboratory services within the broader healthcare ecosystem.
Ownership and Autonomy: Take ownership of the laboratory's success, demonstrating initiative and autonomy in driving growth and achieving strategic objectives.

Qualifications:

Education: A Ph.D. in Molecular Biology, Genetics, Biochemistry, or a closely related field is required.
Sign Off: Must meet the necessary qualifications under CLIA and relevant state regulations to authorize and sign off on clinical laboratory test reports for physician delivery.
Experience:
Minimum of 4+ years of progressive experience in a molecular diagnostics laboratory setting, with significant experience in RNA and DNA sequencing technologies. Board certification (e.g., ABMG) is highly desirable.
Demonstrated experience successfully managing and leading a high-complexity CLIA-certified laboratory.
Proven track record of successfully navigating CLIA audits and maintaining compliance with state and federal regulations.
Experience in developing and implementing Standard Operating Procedures (SOPs) and quality assurance programs.
Experience with budget management and P&L responsibility.
Strong understanding of laboratory operations, workflow optimization, and best practices.
Experience in managing and auditing laboratory materials and vendors.
Skills:
Extensive knowledge of molecular biology principles, genetics, and genomics.
Proficiency in RNA and DNA extraction, quantitation, library preparation, and sequencing technologies.
Familiarity with various microscopy techniques, including dark field microscopy.
Strong understanding of bioinformatics principles and experience coordinating the development of bioinformatics pipelines.
Excellent leadership, communication (written and verbal), and interpersonal skills.
Strong problem-solving and decision-making abilities.
Ability to work independently and as part of a multidisciplinary team.  
A passion for innovation and continuous improvement.

Preferred Qualifications:

Experience with CAP accreditation.
Experience in a startup or new laboratory development environment.
Direct experience in developing and validating new genetic assays.
Familiarity with LIMS (Laboratory Information Management Systems).

Job Type: Full-time

Pay: $120,000.00 - $170,000.00 per year

Benefits:

401(k)
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance

Application Question(s):

Have you directly managed a high-complexity CLIA-certified laboratory?
Do you have hands-on experience with both RNA and DNA sequencing?
Describe your experience with bioinformatics in the context of genomic data analysis in a few brief sentences.
Have you had CLIA audit experience?
Briefly describe your experience leading a team in a laboratory environment.

Work Location: In person

Confidential

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