Molecular Technical Lead

Molecular Technical Lead

Analyze Pathology | Knoxville, TN | Full-Time | On-Site

***PLEASE CAREFULLY REVIEW JOB REQUIREMENTS PRIOR TO APPLYING. NO ONE WILL BE CONSIDERERED WITHOUT PROPER CREDENTIALS DUE TO REGULATORY COMPLIANCE REQUIREMENTS***

About Us

Analyze Pathology is a growing diagnostic pathology laboratory organization serving healthcare providers throughout the United States. Our continued expansion includes the development of high-complexity molecular diagnostic testing services to complement our established anatomic pathology operations.

With an experienced laboratory leadership team, established quality systems, regulatory expertise, and operational infrastructure, Analyze Pathology provides an opportunity for experienced laboratory professionals to contribute to the development of new diagnostic services within a rapidly growing organization.

We are seeking a highly motivated Molecular Technical Lead who is interested in helping build and shape our molecular diagnostics program while maintaining the highest standards of laboratory quality, regulatory compliance, and patient care.

Position Overview

Analyze Pathology is seeking an experienced Molecular Technical Lead to support the development, implementation, and daily operations of our expanding high-complexity molecular diagnostics department.

This position combines hands-on molecular diagnostic testing with technical leadership, assay validation, quality management, and operational development responsibilities.

The successful candidate will play an important role in establishing efficient laboratory workflows, implementing and validating molecular assays, developing technical procedures, maintaining regulatory compliance, and supporting the training and development of laboratory personnel.

This is a collaborative, hands-on leadership opportunity for an individual who enjoys building laboratory systems, solving technical challenges, and contributing to the long-term growth of a diagnostic laboratory.

The position will primarily support later-day to evening operations to facilitate same-day molecular testing turnaround.

Relocation assistance may be available for highly qualified candidates.

Essential Responsibilities

Molecular Testing and Technical Operations

• Perform and oversee high-complexity molecular diagnostic testing.
• Support the development, implementation, and expansion of molecular laboratory services.
• Participate in assay validation, verification, optimization, and troubleshooting.
• Assist with instrumentation selection, installation, qualification, implementation, and vendor coordination.
• Independently troubleshoot assay, instrumentation, technical, and workflow issues.
• Monitor assay performance, quality control results, proficiency testing, and laboratory quality indicators.
• Develop and optimize laboratory workflows to support accuracy, efficiency, scalability, and timely turnaround.

Quality Systems and Regulatory Compliance

• Develop, review, implement, and maintain laboratory documentation, including:
• Standard Operating Procedures (SOPs)
• Assay validation and verification protocols and reports
• Quality Control (QC) procedures
• Quality Assurance (QA) programs
• Training and competency assessments
• Corrective and Preventive Action (CAPA) documentation
• Technical and operational workflows
• Support compliance with CLIA, COLA, Tennessee Medical Laboratory Board requirements, and other applicable regulations.
• Participate in regulatory inspections, proficiency testing, quality improvement initiatives, and corrective action investigations.
• Maintain accurate, complete, and inspection-ready laboratory records.

Leadership and Laboratory Development

• Assist with training, competency assessment, and technical oversight of laboratory personnel.
• Provide technical guidance and support to molecular laboratory staff.
• Collaborate with laboratory leadership, pathology operations, accessioning, histology, and LIS/IT personnel.
• Identify opportunities to improve laboratory processes, quality, productivity, and turnaround times.
• Contribute to staffing development, workflow planning, and continued expansion of molecular diagnostic services.
• Support the development of a collaborative, accountable, and quality-focused laboratory environment.

Minimum Qualifications

Education

Bachelor's degree or higher in an appropriate biological, chemical, or clinical laboratory science, including:

• Medical Laboratory Science (MLS/CLS)
• Medical Technology
• Molecular Biology
• Microbiology
• Biology
• Biochemistry
• Chemistry
• Genetics
• Clinical Laboratory Science
• Other qualifying biological or chemical science meeting applicable requirements

Certification

Current national certification at the technologist level, such as:

• MLS(ASCP)
• MT(ASCP)
• MB(ASCP)
• MLS(AMT)
• MT(AAB)
• MDxT(AAB)
• Other equivalent recognized certification

Tennessee Licensure

Candidates must meet all applicable Tennessee licensure requirements for the position.

Experience and Technical Skills

• Minimum four (4) years of full-time clinical laboratory experience following qualification as a technologist.
• Minimum two (2) years of molecular diagnostics experience.
• Demonstrated experience performing and troubleshooting PCR and real-time PCR assays.
• Experience with molecular assay validation and verification.
• Experience with laboratory quality systems, QC, QA, and technical documentation.
• Experience working in a CLIA-regulated high-complexity laboratory.
• Strong technical writing, organizational, and problem-solving skills.
• Ability to work independently, prioritize responsibilities, and maintain accuracy in a high-volume environment.

Preferred Qualifications

• MB(ASCP) certification.
• Previous experience as a Molecular Technical Lead, Lead Technologist, Laboratory Supervisor, or General Supervisor.
• Experience developing, launching, or expanding molecular diagnostic services.
• Experience preparing for or participating in CAP, COLA, or CLIA inspections.
• Experience with infectious disease molecular testing.
• Experience with molecular oncology testing.
• Experience with QuantStudio or comparable real-time PCR platforms.
• Experience implementing new instrumentation and laboratory workflows.
• Experience training, mentoring, and assessing laboratory personnel.
• Familiarity with laboratory information systems (LIS), middleware, and instrument interfaces.

Schedule

Full-Time | On-Site | Later-Day to Evening Shift

This position will primarily support later-day to evening laboratory operations to facilitate same-day molecular diagnostic testing and timely reporting.

Some scheduling flexibility will be required as testing volumes, laboratory services, and operational needs continue to evolve.

What We're Looking For

Our ideal candidate is a technically strong molecular laboratory professional who enjoys both hands-on testing and operational leadership.

We are particularly interested in individuals who:

• Take ownership of responsibilities and proactively solve problems.
• Demonstrate excellent attention to detail and commitment to quality.
• Work independently while collaborating effectively with other departments.
• Enjoy developing processes, improving workflows, and establishing operational structure.
• Adapt well to changing priorities in a growing laboratory environment.
• Maintain high standards of accountability, documentation, and regulatory compliance.
• Enjoy mentoring colleagues and contributing to team development.
• Are motivated by the opportunity to help shape and expand a molecular diagnostics program.

Why Join Analyze Pathology?

This position offers an opportunity to contribute directly to the growth of molecular diagnostics within an established and expanding pathology organization.

Unlike positions focused exclusively on routine testing, this role provides meaningful involvement in assay implementation, laboratory workflow design, quality systems, technical operations, and future service development.

The successful candidate will work closely with experienced laboratory leadership and have an opportunity to influence the direction and continued growth of our molecular diagnostics department.

Benefits

• 401(k)
• Health insurance
• Dental insurance
• Vision insurance
• Paid time off
• Relocation assistance may be available for highly qualified candidates

Work Location: In person, Knoxville, Tennessee

Employment Type: Full-time

Analyze Pathology is an Equal Opportunity Employer.

Pay: From $68,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person