Manager, Clinical Laboratory

Employer
GRAIL, Inc.
Location
Menlo Park, CA, United States
Posted
Feb 14, 2021
Ref
1931857180
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.

The Clinical Laboratory Manager is responsible for the overall operations of the Clinical Laboratory and the supervision of laboratory personnel. The high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multitask, be flexible with tasks and schedules, and the ability to work independently in a team environment. The Clinical Laboratory Manager will act as a liaison between the laboratory staff and the Product Development, Process Engineering, Bioinformatics, Software and Materials Management groups.

The Clinical Laboratory Manager will also be involved with scheduling, troubleshooting high complexity technical and non-technical problems, coaching and mentoring laboratory staff, building effective teams, managing projects and meeting project deliverables, and understanding and implementing laboratory goals.

You Will:

• Oversee the overall operations of the Clinical Laboratory including, but not limited to ensuring test systems are functioning properly, monitoring patient and quality control testing results, planning, validation and implementation of new test procedures, and supervision of laboratory personnel.
• Work with other laboratory personnel on the laboratory's quality control and quality assurance procedures, technical troubleshooting and improvement procedures, and training
• Manage stability studies, validation protocols, and other process improvement and new assay projects.
• Review validation and stability study protocols and technical reports.
• Write and review standard operating procedures.
• Provide direct supervision to testing personnel.
• Perform analytical procedures including testing, quality control, preparation and aliquoting of reagents and analyses according to the laboratory's standard operating procedures.
• Operate and maintain laboratory instruments and equipment according to laboratory standard operating procedures
• Troubleshoot and problem solve instrument issues.
• Check, monitor and record temperature and perform root cause analysis of deviations and implement a resolution or initiate a service request as necessary.
• Review, interpret and report patient results as assigned.
• Resolve high complexity problems that adversely affect the test performance.
• Perform, review and document laboratory quality control procedures.
• Perform and document reagent qualifications per the approved protocols.
• Resolve all corrective actions taken when test systems deviate from the laboratory's established performance specifications.
• Participate in the introduction of assay improvements, new assay configurations and validation.
• Participate and comply with Quality and applicable regulatory requirements.
• Participate in cross-functional teams responsible for securing CLIA certification, CAP accreditation, and state licensure for the GRAIL Clinical Laboratory, including compliance with all applicable standards and regulations.
• Communicate effectively with coworkers and non-laboratory personnel.
• Perform other laboratory duties as needed.

Your Background Should Include:

• A valid California Clinical Laboratory Scientist license
• Bachelor of Arts or Science in Biomedical Laboratory Science, Clinical Science or related field
• Experience in molecular biology techniques preferred
• Working knowledge of local, state and federal laboratory regulations preferred
• At least seven years of Laboratory experience or equivalent
• Supervisory experience preferred
• High volume laboratory experience preferred
• Outstanding professionalism, leadership and communication skills
• Strong analysis, problem solving skills and project management
• Strong technical skills and job and industry knowledge
• Able to integrate and apply feedback in a professional manner
• Able to prioritize and drive to results with a high emphasis on quality
• Ability to effectively communicate technical information to technical and non-technical audiences
• Ability to work as part of a team within a highly collaborative environment
• Strong computer skills
• Ability to analyze and solve complex issues that impact the performance of the assay
• Ability to proactively communicate consistently, clearly and honestly
• Ability to prioritize tasks with a high emphasis on quality
• Flexibility of work schedule to meet the needs of GRAIL's Clinical Laboratory

Physical Demands/Working Environment:

• Hours and days may vary depending on operational needs
• Standing or sitting for long periods of time may be necessary
• May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation
• Repetitive manual pipetting may be necessary
• Some lifting (up to 25 pounds) may be necessary

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.