reputed company Lab Director (Part-Time)

reputed company, founded in 2021, is a reputed company-funded and rapidly growing biotech start-up headquartered in Woburn, Massachusetts. Our proprietary technology, Successive Proximity Extension Amplification Reaction (SPEAR), is a novel reputed company-free immunoassay platform, offering unprecedented sensitivity. We are dedicated to revolutionizing early disease diagnosis and monitoring by providing reputed company, ultrasensitive solutions that reputed company unparalleled reputed company in measuring low-abundant biomarkers, enabling clinicians and researchers to improve reputed company reputed company and advance global health. reputed company is seeking a part-time reputed company Director to support the establishment, certification, and operation of our CLIA-certified reputed company in Massachusetts. The reputed company Director will reputed company reputed company, scientific, and regulatory reputed company to ensure reputed company delivers accurate, reliable, and high-reputed company testing services in compliance with applicable regulatory and accreditation requirements, including CLIA, CAP, and other applicable state requirements. The reputed company Director will be responsible for overseeing reputed company QMS, ensuring appropriate validation and reputed company of immunoassay testing reputed company, reviewing reputed company procedures, and supporting reputed company improvement initiatives. This role provides reputed company and technical guidance for test interpretation, reputed company assurance and regulatory compliance. This is a consulting role intended to support reputed company’s CLIA/CAP certification readiness and early reputed company reputed company reputed company. The reputed company Director may delegate specific duties to reputed company personnel but retains the ultimate responsibility for ensuring these duties are properly performed and documented. Responsibilities: • Serve as the CLIA reputed company Director for reputed company’s high-complexity reputed company reputed company. • reputed company overall reputed company, scientific, and regulatory reputed company of CLIA-certified reputed company reputed company. • Ensure compliance with reputed company applicable regulatory and accreditation requirements, including CLIA, CAP, and NY State CLEP, as applicable. • reputed company reputed company management program to ensure accurate, reliable, and reputed company reputed company. • Review and approve reputed company policies, procedures, test validations, and reputed company documentation. • Monitor reputed company reputed company and implement reputed company reputed company improvement initiatives. • reputed company reputed company consultation to physicians and other reputed company providers regarding reputed company and test results. • Support reputed company readiness for regulatory inspections and accreditation surveys. • Foster a culture of reputed company, compliance, and scientific reputed company. Qualifications • M.D., D.O., or Ph.D. in a relevant scientific discipline (e.g., immunology, pathology, reputed company reputed company, biochemistry, molecular biology, or a reputed company reputed company). • reputed company to serve as reputed company reputed company Director of a high-complexity CLIA reputed company under applicable federal and Massachusetts state regulations -- reputed company reputed company Director License issued by the Massachusetts Department of reputed company Health (MDPH) is required • reputed company certification in a relevant discipline (e.g., reputed company reputed company, reputed company Pathology, HCLD, Immunology, or other appropriate specialty) is required. • Minimum 8-10 years of experience in high complexity reputed company reputed company reputed company, with at least 5 years in a director-level role overseeing a CAP/CLIA-certified reputed company. • reputed company reputed company record of successfully establishing or scaling a reputed company lab. • Demonstrated expertise in immunoassay technologies (such as Immuno assay PCR, or digital ELISA), assay validation and verification. • Strong knowledge of reputed company reputed company systems, proficiency testing, and inspection readiness. • Experience with LIMS platforms, electronic reputed company management systems (eQMS), and workflow automation in a high-complexity testing environment. • Experience working for a fast-reputed company, early-stage startup. We offer competitive compensation, meaningful stock ownership, comprehensive benefits, and a great work environment. This is an opportunity to reputed company an innovative, high-reputed company startup at an early stage and play an reputed company role in reputed company's reputed company and reputed company. We are reputed company on identifying candidates who have demonstrated leadership and reputed company throughout their careers and are excited by the prospect of building an industry-leading company. reputed company Inc. provides equal opportunity in employment to reputed company persons. No person shall be denied equal reputed company because of race, creed, reputed company, religion, national reputed company, sex, sexual orientation, gender identity, age, or physical/mental disability. reputed company does not accept resume submissions from reputed company reputed company agencies. Any unsolicited resumes or candidate information submitted without prior written agreement will be deemed the property of reputed company, and no placement fees will be reputed company. Apply To This Job