CLIA Laboratory Manager - Anatomic Pathology

Be a part of the future of Precision Medicine! Our mission is to improve the human condition by bringing the power of precision medicine to labs, partners and patients globally. In the Companion Diagnostics Business (CDx), our team partners very closely with leading biopharma companies to develop, manufacture and commercialize highly regulated medical devices which are critical for physicians to help select therapies for their patients.

The CLIA Lab Manager is responsible for a CLIA and CAP accredited and NYS permitted laboratory, residing in Carpinteria, California, performing Clinical-Trial retrospective and prospective testing services.  This position is responsible for overseeing all laboratory operations, ensuring strict compliance with all state and federal CLIA regulations, managing personnel and quality assurance programs to ensure accurate and reliable analytical test results. Additionally, the Lab Manager will support Business Development, presenting our Clinical-Trial services capabilities to both current and future customers for new business opportunities.

Must demonstrate ability to work independently, exercise good judgement, work collaboratively in an interdisciplinary team with minimal direction, and to thrive in a fast-paced environment. Effective verbal and written communication skills with attention to detail and excellent problem-solving skills with demonstrated leadership ability.
 

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• Manage day-to-day operations, including workflow, staffing schedules, and resource allocation to ensure efficiency and timely delivery of service to our customers.

• Ensure full compliance with all federal and state (CLIA-CDPH-LFS) regulations and accreditation standards (e.g., CAP, NYSDOH).

• Maintain current laboratory licenses and certifications, collaborate with Quality Assurance support for handling renewals and changes as needed.

• Prepare the laboratory for inspections and audits by regulatory bodies.

• Develop, implement, and maintain quality management systems and standard operating procedures (SOPs).

• Oversee quality control programs, proficiency testing & performance, and implement corrective actions when deviations occur.

• Analyze test result data, prepare performance reports, and lead continuous quality improvement initiatives.

• Supervise, hire, train, and mentor laboratory staff (Clinical Laboratory Scientists, Lab Assistants, Histotechnologists, etc.).

• Conduct annual performance and competency evaluations, ensuring all personnel are appropriately trained and documented before testing Clinical-Trial specimens.

• Foster a collaborative and safe work environment, enforcing all safety protocols and addressing potential hazards immediately.

• Bachelor of Science degree in Medical Technology, clinical/medical laboratory science, biological science, related life science field, or equivalent from an accredited institution AND 4+ years working in a high complexity testing laboratory with a doctoral level Laboratory Director. 

OR

• Master’s degree in medical technology, clinical laboratory science, chemical, physical, or biological science AND 4+ years working in a a high complexity testing clinical laboratory with a doctoral level Laboratory Director. 

OR

• PhD degree in medical technology, clinical laboratory science, chemical, physical or biological science AND 2+ years working in a high complexity testing clinical laboratory with a doctoral level Laboratory Director.

• Basic understanding of companion diagnostics and drug development.
• Practical experience with anatomic pathology and immunohistochemistry.
• Validation of LDT’s for companion diagnostics testing for Clinical-Trials.
• Experience with other diagnostic modalities such as in situ hybridization and flow cytometry.
• HTL/HT (ASCP) Certification.
• Knowledge or experience with lab automation, including implementation of a Laboratory Information Management System.

• Possess a current California laboratory technologist license (CLS generalist).
• 3+ years of people leadership experience with accountability for clinical laboratory direct reports.
• High complexity clinical laboratory experience, with knowledge of anatomic pathology, histological techniques, and Immunohistochemistry.
• Experience in clinical document writing for laboratory SOP’s and validations.
• Clinical-Trial testing and reporting experience.
• Willing to be hands on.