CLIA Laboratory Manager

Job Description
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 pharmaceutical companies to develop, manufacture and commercialize highly regulated medical devices which are critical for physicians to help select therapies for their patients.
Work in a dynamic environment in the field of Oncology! The Laboratory Manager of the CLIA high complexity Histology laboratory will oversee the establishment and maintenance of the CLIA & CAP regulated laboratory for the Companion Diagnostic development group at Agilent Technologies. This position will be involved in establishing a CLIA & CAP certified laboratory as well as manage the day-to-day operations once the lab is operational. Initially this person would fill the role of Technical Supervisor and testing personnel. Establish and maintain SOP and process/instrument validation activities. Perform day-to-day Histology operations (accessioning, embedding, cutting, staining, digital scanning of clinical tissue samples). Identify deviations in test processes and correct as necessary. Ensure proper documentation/traceability/validation of testing operations. Perform and document instrument and equipment use, calibration and maintenance. As the laboratory grows will be responsible for the day-to-day supervision and training of the personnel performing testing, reporting of test results, and overall QC monitoring.
Must demonstrate ability to work independently, exercise good judgement, to work collaboratively in an interdisciplinary team with minimal direction, and to thrive in a fast-paced environment. Ability to advocate strategically effective solutions to complex problems and to influence and negotiate solutions across the organization. Effective verbal and written communication skills and attention to detail with an ability to work in a highly regulated environment. Excellent problem-solving skills and demonstrated leadership ability.
Responsibilities:

• Work under the direction of the Laboratory Director and/or Chief Pathologist.
• Direct supervision of laboratory personnel performing high complexity testing (IHC).
• Develop and maintain personnel competency and training.
• Establish and maintain SOP's.
• Order and manage lab equipment and inventories.
• Set and maintain department budgets.
• Collaborate cross-functionally across other departments/divisions such as RA/QA to ensure compliance.
• Work with external vendors and regulatory agencies such as CLIA & CAP
• Digital Scanning of Microscope Slides.
• Review patient testing results to ensuring none are reported until any necessary corrective actions have been taken and test system is functioning properly.
• Ensure that all remedial actions are taken whenever test systems deviate from the established performance specifications.
• Participate in individual staff and team goal setting.
• Ensure Good Documentation Practices (GDP); sign as "designee" of Lab Director on workgroup or data analysis forms for all assays.
• Responsible for appropriately accessing and safeguarding Protected Health Information (PHI) and all other confidential information.
• This position requires adhering to established laboratory policies/guidelines while maintaining a safe working environment. This position will require accurate document recording to comply with various internal and external regulations.

Qualifications

• Bachelor's degree in medical technology, clinical/medical laboratory science, chemical, physical, molecular biology, genetics, biological science, related life science field, or equivalent from an accredited institution AND six years of experience working hands-on in a clinical laboratory with at a minimum two years working in a laboratory with a doctoral level Laboratory Director; OR Master's degree in medical technology, clinical laboratory science, chemical, physical, or biological science AND four years working in a clinical laboratory with at a minimum two years working in a laboratory with a doctoral level Laboratory Director.
• HTL/HT (ASCP) Certification required.
• 6+ years' experience working in a clinical laboratory.
• 2+ years' experience working under doctoral level laboratory director.
• Experience with Good Laboratory Practices (GLP) and Standard Operating Procedures (SOP's).
• Clinical laboratory management experience.
• High complexity clinical laboratory experience, with knowledge of Histological techniques in Immunohistochemistry.
• Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel).
• Effective verbal and written communication skills.

Preferred Qualifications:

• Experience with other diagnostic modalities such as Flow Cytometry and Mass Spectrometry.
• Knowledge or experience with lab automation.
• Practical and hands-on experience in Quality Management Systems (QMS).
• Experience in clinical document writing for laboratory SOP's and validations.
• Able to manage staff/employees.
• Clinical trial experience.

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The US pay range for this full-time position is $142,632.00 - $222,863.00/yr, plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position across the relevant US locations. 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. Additional details are available at: https://careers.agilent.com/locations/americas/united-states/
Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity 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 diversity in the workplace 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 www.agilent.com/en/accessibility.
Travel Required
Occasional
Schedule
Schedule:Full time
Shift
Day
Duration
No End Date
Job Function
R&D