CLIA Laboratory Director (Part-time / Consultant)

Sustainable World, Inc.; Burlington (MA); Hybrid; USD 61,000 - 73,000; Part time

Benefits offered by this job

Travel to Heidelberg twice yearly

Travel to Burlington, MA twice yearly

Job summary

ProtaGene invites a part-time Laboratory Director to oversee two CLIA laboratories in Burlington, MA, and Heidelberg, Germany. The role ensures adherence to CLIA, CAP, and state requirements through method reviews, validation, and staff competency oversight.

The ideal candidate will possess MD/DO or doctoral qualifications with relevant board certification and substantial experience directing high-complexity testing, supporting inspections and compliance needs.

Qualifications

• Eligible to serve as Clinical Laboratory Director for two CLIA laboratories performing high-complexity testing, per 42 CFR §493.1443 and MA/PA/CA requirements.
• MD/DO license in Massachusetts with board certification in pathology, or doctoral degree with HHS-approved specialty board.
• For non-physician candidates, at least two years of lab training/experience and two years directing high-complexity testing.

Responsibilities

• Act as Part-time/Consultant Laboratory Director for two CLIA labs in Burlington, MA and Heidelberg, Germany.
• Ensure compliance with CLIA, CAP, and state requirements including MA, CA, PA; NY qualification asset.
• Review and approve test methods, validation, procedures, and reporting formats.
• Oversee laboratory personnel training, competency, and delegated responsibilities.
• Conduct minimum two on-site oversight visits per calendar year to each lab location; travel costs covered separately.
• Review quality-control and proficiency testing data and take corrective actions as needed.
• Provide scientific and clinical consultation on complex technical, quality, or compliance matters.
• Support regulatory inspections and license applications; assist customer audits.
• Participate in oversight meetings/site visits and respond to significant quality or patient impact events.
• Maintain documentation of oversight, reviews, decisions, and delegated responsibilities.
• Contribute to corporate safety, environmental and quality standards.

Skills

Clinical Laboratory Director eligibl

Molecular diagnostics experience

Regulatory compliance knowledge

Leadership and oversight

Education

MD/DO licensed in MA or equivalent

Doctorate in chemical/biological/medical lab science

2+ years directing high-complexity testing

Job description

Your Responsibilities:

• Act as Part-time/Consultant Laboratory Director for ProtaGene’s two CLIA high-complexity laboratories in Burlington,Massachusetts, USA and Heidelberg, Germany, in accordance with 42 CFR §§493.1441 and 493.1445.


• Ensure both laboratories operate in compliance with applicable CLIA, CAP, and relevant state requirements, includingMassachusetts, California, and Pennsylvania requirements; New York State qualification considered an asset.


• Review and approve relevant test methods, validation activities, procedures, report formats, and major changes affectingclinical testing.


• Oversee the suitability, training, competency, and delegated responsibilities of laboratory personnel involved in high complexity testing.


• Conduct a minimum of two on-site oversight visits per calendar year to each laboratory location (Burlington and Heidelberg),with travel costs covered separately.


• Review quality-control, proficiency testing/alternative assessment, and performance data; ensure appropriate action is takenwhere issues are identified.


• Provide scientific and clinical consultation on complex technical, quality, reporting, or compliance matters.


• Support regulatory inspections, CAP/CLIA activities, licence applications, and customer audits as needed.


• Participate in scheduled oversight meetings and site visits, and remain available for significant quality, regulatory, or patient impact events.


• Maintain appropriate documentation of oversight, reviews, decisions, and delegated responsibilities.


• Contribute to and comply with corporate safety, environmental, and quality standards.

Note: The Laboratory Director retains independent professional authority and accountability for the quality, reliability, andregulatory compliance of testing performed under each laboratory’s CLIA certificate.

Note:While the ideal candidate shall be available for both ProtaGene laboratories, those capable of holding only one of the twosites may also be considered.

We Offer:

• This is a part-time consulting role requiring a commitment of 12 consulting hours per month across both laboratories.


• A minimum of 12 hours of consulting work per month at a rate of $500/hr for a minimum monthly total of $6000.


• Two paid visits to the company’s site in Heidelberg, Germany, per year, with travel time and reasonable travel expenses compensated separately.


• Two paid visits to the company’s site in Burlington, MA, USA, per year, with travel time and reasonable travel expenses compensated separately.


• Work for a dynamic, innovative company that values appreciation, openness and respect as well as a lively feedback culture.

We are looking forward to receiving your complete application documents through our website.
Application CLIA Laboratory Director
(https://careers.protagene.com/o/clia-laboratory-director-mfd)

Your Qualifications:

• Eligible to serve as Clinical Laboratory Director for two CLIA laboratories performing high-complexity testing, in accordance with 42 CFR §493.1443, 105 CMR 180.060, and any applicable requirements for California and Pennsylvania laboratory licensure.


• Meet the applicable Massachusetts and CLIA director-qualification pathway, including either:
  
  
  
  • MD or DO licensed to practise in Massachusetts and board-certified in anatomic and/or clinical pathology; or
  
  
  • Earned doctoral degree in a chemical, biological, clinical, or medical laboratory science, medical technology, molecular
    biology, genetics, genomics, or a closely related discipline, together with certification by an HHS-approved andMassachusetts-acceptable specialty board.
  
  
  • For non-physician candidates, at least two years of laboratory training and/or experience and at least two years’experience directing or supervising high-complexity testing in the relevant specialty.
  
  


• Board certification in clinical molecular genetics/genomics or a directly relevant specialty is required or strongly preferred,depending on the candidate’s CLIA qualification pathway (e.g., ABMGG or another HHS-approved board).


• Demonstrated experience in clinical molecular diagnostics, genomics, NGS and/or other high-complexity genetic testingrelevant to the laboratory’s test menu.


• Strong working knowledge of CLIA, CAP accreditation, Massachusetts clinical laboratory requirements, method validation/verification, proficiency testing or alternative assessment, personnel competency, quality control, and clinical reporting.


• Ability to meet additional laboratory-director, technical-director, or state qualification requirements for jurisdictions in whichthe laboratory holds, or intends to obtain, licences or permits. A minimum of California and Pennsylvania is required.


• Integrity, commitment, and a motivated work ethic.


• Ability to work in a team and independently.


• Strong organizational and interpersonal skills.


• Ability to troubleshoot, solve difficult problems, and propose solutions relating to laboratory organization and management.


• Self-motivated, curious and results oriented with minimal oversight.


• Effective collaborator with internal and external partners to develop and maintain the overall strategies.


• Excellent written and verbal communication skills, ability to work well with colleagues from diverse backgrounds and cultures.