spearbio - Clinical Lab Director (Part-Time)
Requirements
• M.D., D.O., or Ph.D. in a relevant scientific discipline (e.g., immunology, pathology, clinical chemistry, biochemistry, molecular biology, or a related field). • Qualified to serve as Clinical Laboratory Director of a high-complexity CLIA laboratory under applicable federal and Massachusetts state regulations -- Clinical Laboratory Director License issued by the Massachusetts Department of Public Health (MDPH) is required • Board certification in a relevant discipline (e.g., Clinical Chemistry, Clinical Pathology, HCLD, Immunology, or other appropriate specialty) is required. • Minimum 8-10 years of experience in high complexity clinical laboratory operations, with at least 5 years in a director-level role overseeing a CAP/CLIA-certified laboratory. • Proven track record of successfully establishing or scaling a clinical lab. • Demonstrated expertise in immunoassay technologies (such as Immuno assay PCR, or digital ELISA), assay validation and verification. • Strong knowledge of laboratory quality systems, proficiency testing, and inspection readiness. • Experience with LIMS platforms, electronic quality management systems (eQMS), and workflow automation in a high-complexity testing environment. • Experience working for a fast-paced, early-stage startup. • We offer competitive compensation, meaningful stock ownership, comprehensive benefits, and a great work environment. This is an opportunity to enter an innovative, high-growth startup at an early stage and play an integral role in the company's growth and success. We are focused on identifying candidates who have demonstrated leadership and excellence throughout their careers and are excited by the prospect of building an industry-leading company. • Spear Bio Inc. provides equal opportunity in employment to all persons. No person shall be denied equal access because of race, creed, color, religion, national origin, sex, sexual orientation, gender identity, age, or physical/mental disability. • Spear Bio does not accept resume submissions from external recruiting agencies. Any unsolicited resumes or candidate information submitted without prior written agreement will be deemed the property of Spear Bio, and no placement fees will be paid.
Responsibilities
• Serve as the CLIA Laboratory Director for Spear Bio’s high-complexity clinical laboratory. • Provide overall clinical, scientific, and regulatory oversight of CLIA-certified laboratory operations. • Ensure compliance with all applicable regulatory and accreditation requirements, including CLIA, CAP, and NY State CLEP, as applicable. • Oversee quality management program to ensure accurate, reliable, and timely laboratory testing. • Review and approve laboratory policies, procedures, test validations, and quality documentation. • Monitor laboratory performance and implement continuous quality improvement initiatives. • Provide clinical consultation to physicians and other healthcare providers regarding laboratory testing and test results. • Support laboratory readiness for regulatory inspections and accreditation surveys. • Foster a culture of quality, compliance, and scientific excellence.
Benefits
• Competitive and commensurate with experience $0 – $1 per hour • Upload your resume here to autofill key application fields. • Drop your resume here! • Parsing your resume. Autofilling key fields... • or drag and drop here • Board-Certified Physician: I am a M.D. or D.O. with active American board certification in an applicable laboratory specialty, such as Clinical Pathology, Anatomic and Clinical Pathology, Clinical Chemistry, or another accepted specialty clinically relevant to the laboratory’s immunoassay test menu. • Doctoral Degree + Board Certification: I hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and also maintain active board certification in an applicable laboratory specialty by an accepted board such as the American Board of Clinical Chemistry, Clinical Pathology, Medical Microbiology, Medical Laboratory Immunology, or another equally accepted board. • None of the above • As this is a legally mandated requirement, we are unable to proceed with an interview if a copy of this certification cannot be provided. • Local (Boston Metro Area) • Reside outside of the Boston Metro Area • M.S. or equivalent • B.S. or equivalent • Yes, I have prior experience establishing/overseeing the certification of a CLIA lab • Yes, I have experience working with an already-established clinical lab, and was instrumental in scaling it • No, I do not have experience establishing/overseeing the certification of, or scaling a clinical lab • I do not have experience overseeing a CAP/CLIA-certified laboratory • Decline to self-identify • Hispanic or Latino - A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin regardless of race. • Hispanic or Latino • White (Not Hispanic or Latino) - A person having origins in any of the original peoples of Europe, the Middle East, or North Africa. • White • Black or African American (Not Hispanic or Latino) - A person having origins in any of the black racial groups of Africa. • Black or African American • Native Hawaiian or Other Pacific Islander (Not Hispanic or Latino) - A person having origins in any of the peoples of Hawaii, Guam, Samoa, or other Pacific Islands. • Native Hawaiian or Other Pacific Islander • Asian (Not Hispanic or Latino) - A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian Subcontinent, including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. • Asian • American Indian or Alaska Native (Not Hispanic or Latino) - A person having origins in any of the original peoples of North and South America (including Central America), and who maintain tribal affiliation or community attachment. • American Indian or Alaska Native • Two or More Races (Not Hispanic or Latino) - All persons who identify with more than one of the above five races. • Two or More Races • Hispanic or Latino • White (Not Hispanic or Latino) • Black or African American (Not Hispanic or Latino) • Native Hawaiian or Other Pacific Islander (Not Hispanic or Latino) • Asian (Not Hispanic or Latino) • American Indian or Alaska Native (Not Hispanic or Latino) • Two or More Races (Not Hispanic or Latino) • I identify as one or more of the classifications of protected veteran listed above • I am not a protected veteran
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