Job Description

Job DescriptionBe 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.Key Responsibilities:Operational Leadership:Manage day-to-day operations, including workflow, staffing schedules, and resource allocation to ensure efficiency and timely delivery of service to our customers.Regulatory Compliance: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.Quality Assurance & Control (In partnership with Quality Assurance):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.Personnel Management: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.QualificationsBachelor 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. ORMaster’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. ORPhD 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.Other: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 experienceExperience in clinical document writing for laboratory SOP’s and validations.Clinical-Trial testing and reporting experience.Validation of LDT’s for companion diagnostics testing for Clinical-TrialsWilling to be hands on.Preferred Qualifications:Knowledge of anatomic pathology, histological techniques, and Immunohistochemistry.Basic understanding of companion diagnostics and drug development.Practical experience with anatomic pathology and immunohistochemistry..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.Additional DetailsThis job has a full time weekly schedule. Applications for this job will be accepted until at least August 27, 2026 or until the job is no longer posted.The full-time equivalent pay range for this position is $160,500.00 - $250,781.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit Required: OccasionalShift: DayDuration: No End DateJob Function: R&DSummaryLocation: US-CA-CarpinteriaType: Full time

Job Tags

Similar Jobs