Your Responsibilities
Act as part-time/consultant Laboratory Director for ProtaGene’s two CLIA-certified 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, including Massachusetts, 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 affecting clinical 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 taken where 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, and regulatory 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 two sites may also be considered.
Eligible to serve as Clinical Laboratory Director for two CLIA-certified 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 and Massachusetts-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 testing relevant 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 which the 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.
What 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.