Lab Director - Fractional/Part Time

Dash Bio; Waltham (MA); On-site; USD 165,000 - 358,000; Part time

Benefits offered by this job

Competitive compensation

Comprehensive benefits

Direct access to industry veterans

Job summary

Dash Bio is seeking a qualified Laboratory Director (fractional/contract) in Massachusetts to oversee the laboratory through CLIA certification and into ongoing compliance. The Director will hold overall responsibility for operations under 42 CFR Part 493 and be named on the CMS-116 application, delegating duties in writing while remaining accountable.

The role requires an active MA license and a pathway that supports high-complexity testing, with on-site oversight and quarterly to biannual

Qualifications

• Must hold a current Massachusetts state license and meet at least one pathway for the laboratory's complexity level.
• Experience directing or supervising high-complexity testing.
• Ability to prepare CMS-116, procedure manuals, and delegation letters.

Responsibilities

• Direct the laboratory's operation under 42 CFR Part 493, Subpart M.
• Sign the CMS-116 application and oversee initial certification.
• Lead the initial survey and develop plans of correction for any deficiencies.
• Maintain ongoing compliance with CLIA requirements and proficiency testing.

Skills

Laboratory management

Regulatory compliance

Quality control

Education

MD/DO/DPM

Doctoral degree in chemical/biological/clinical lab science

Job description

Company Summary:

Dash accelerates drug development. By fusing advanced automation-native lab workflows and integrated software into a unified platform, we provide the biopharma industry with the high-velocity, high-quality, data-driven development solutions required to get life-saving therapies to patients faster. Dash seeks to continuously improve industry KPIs and materially reduce the time and cost to bring a drug to market.

We are building the infrastructure for modern drug development. We are moving beyond the manual, fragmented processes of traditional service providers by taking a technology-first approach to bioanalysis. Our platform is tech-enabled, automated, and GLP-compliant with the goal to industrialize the scientific workflows that act as bottlenecks in the industry. We deliver next-generation preclinical and clinical bioanalysis results with unprecedented speed and precision.

We are a team of builders operating at the intersection of biology, hardware, and code. This is an environment for scientists and engineers who are tired of the status quo and are ready to apply their skills to solve hard problems at scale. We don't just run assays, we architect the systems that will define the future of drug development.

We are a place where employees are stretched to do the best work of their career. We are looking for engineers, scientists, and biotechnicians who want to make an impact on the world and leverage their skills in an innovative way.

Job Description

Dash is seeking a qualified, board-certified Laboratory Director on a fractional (contract) basis to direct the laboratory through initial CLIA certification (COC) and maintain compliance thereafter for the High Complexity work completed by the Dash team.. The Director will hold overall responsibility for the laboratory's operation and administration under 42 CFR Part 493, Subpart M, and will be named as Laboratory Director on the CMS-116 application.The Director will delegate specific duties in writing to qualified personnel but remains accountable for every delegated function.

Key Responsibilities

Duties follow the director standards in 42 CFR 493.1445 (high complexity).

Certification phase (pre-inspection)

• Review and sign the CMS-116 application; serve as the named Laboratory Director with the State Agency or accrediting organization (CAP, COLA, or The Joint Commission).
• Confirm test menu and complexity categorization; identify the specialties and subspecialties to be listed.
• Approve the laboratory's physical plant, environmental conditions, and safety program as appropriate for the testing performed.
• Establish and approve the procedure manual, including the written policy for director on-site visits and how each visit is documented.
• Approve method verification (moderate-complexity FDA-cleared tests) or full validation (modified tests and LDTs) before any patient testing begins.
• Enroll the laboratory in HHS-approved proficiency testing for every regulated analyte.
• Verify personnel qualifications; appoint technical consultant/supervisor, clinical consultant, general supervisor, and testing personnel in writing with defined duties.
• Approve training and initial competency assessment for all testing personnel.
• Lead the laboratory through the initial survey and sign the plan of correction for any cited deficiencies.

Ongoing compliance (post-certification)

• Be on-site at least once every 6 months, with at least 4 months between the two minimum visits, and document each visit with evidence of director activities performed.
• Remain accessible by phone or electronic means to provide consultation as needed.
• Oversee the quality control and quality assessment programs; review QC, calibration, and corrective actions.
• Review proficiency testing results and attestations; direct investigation and corrective action for unsatisfactory results.
• Ensure competency assessment is performed semiannually in the first year and annually thereafter for each testing employee.
• Ensure test reports contain required information and that results are reported promptly and accurately.
• Review and sign new or revised procedures, and complete periodic procedure reviews.
• Ensure the laboratory is prepared for biennial inspections and maintains records for required retention periods.
• Provide clinical consultation to ordering providers on test selection and result interpretation, directly or through a qualified clinical consultant.

Duties may be delegated in writing to qualified personnel; the Director remains responsible for their proper performance. A director may direct no more than five non-waived laboratories.

Qualifications

Candidates must hold a current state license in the state of Massachusetts and meet at least one pathway below for the laboratory's complexity level, under the personnel rules effective December 28, 2024.

Pathway

High complexity (493.1443)

Pathologist

Board-certified in anatomic and/or clinical pathology

MD / DO / DPM

2 yrs directing or supervising high-complexity testing + 20 hrs director Continuing Education (CE)

Doctoral degree (chemical, biological, or clinical lab science)

HHS-approved board certification + 2 yrs clinical lab experience + 2 yrs supervising high-complexity testing + 20 hrs director CE

All experience and training must have been obtained in a CLIA-certified laboratory. Director Continuing Education must cover the director responsibilities and be completed before qualifying.

Accepted HHS-approved boards for doctoral-level directors include ABB, ABCC, ABMM, ABMLI, ABMGG, ACHI, ASCP BOC, and doctoral-level ABFT or NRCC certifications.

Candidates must also:

• Currently direct no more than four other non-waived laboratories, so this role does not exceed the five-laboratory limit.
• Hold an active, unrestricted medical license in Massachusetts
• Have no CLIA sanctions or exclusions, including the two-year prohibition after directing a laboratory whose certificate was revoked.

Time Commitment

Phase

On-site

Certification (approx. months 1-4)

15 hrs/month

At least one documented visit before the survey; present for the survey if requested

Signed CMS-116, approved procedure manual, verification/validation reports, and delegation letters

Ongoing compliance

6 hrs/month

At least once every 6 months, 4+ months apart

Monthly QC/QA review, PT review and sign-off, competency records, visit reports

Survey and inspection years

As needed

During biennial survey when feasible

Survey readiness review, plan of correction if cited

The Director will be reachable by phone or email during testing hours, with a response time of 3 business days for routine issues and <1 business day for critical issues such as failed QC or PT.

What We Offer

• Opportunity to work at the forefront of bioanalytical innovation.
• Collaborative and inclusive company culture.
• Competitive salary and comprehensive benefits package.
• Direct access to industry veterans and a supportive environment for professional growth.