Xdx - Lab Manager

Title: Clinical Laboratory Manager
Job Code: TO- 07131-W


About XDx:
XDx is a molecular diagnostics company based in Brisbane, California, funded by Kleiner Perkins and other top tier venture capitalists. Setting the stage for a new era in personalized medicine, XDx is one of the first companies to develop and commercialize practical applications built on insights from the Human Genome Project. The company has developed a proprietary new method for noninvasively monitoring the immune system by measuring gene expression in a patient’s peripheral blood. The technology offers the potential to decrease healthcare costs and significantly improve the quality of life for patients with a variety of life-threatening or life-altering, immune-mediated diseases.

Our culture is based on a belief in pioneering and innovation, integrity, people development, community, and balance in our day to day lives. The company offers excellent benefits. This is a place where you can make a difference, learn new skills, and work with outstanding people.


Job Profile:
Under general direction of the Sr. Director, Technical Operations, the Clinical Laboratory Manager is responsible for managing the administrative and technical functions in the XDx Clinical Reference Laboratory. This position will manage the daily operation, quality control and quality assurance activities of the clinical laboratory to ensure quality patient testing and compliance with applicable regulatory requirements (CLIA, CAP, FDA, and OSHA). Job duties will be accomplished through collaboration with other Technical Operations staff as well as other groups throughout XDx.

Responsibilities:
• Interview and evaluate the performance of technologists, technicians and support personnel
• Control staffing levels; coordinate work schedules to maintain adequate coverage for all clinical testing
• Ensure managerial oversight during all hours of the laboratory operation
• Review patient testing and quality control results
• Develop and monitor quality assurance activities, including follow-up of incident reports, non-conformances, and corrective and preventive actions
• Recommend and administer the budget for the laboratory including the selection and purchase of equipment
• Determine and ensure appropriate stock levels of supplies and equipment; ensure that routine equipment calibration and maintenance is performed and reviewed on schedule
• Consult with the Senior Director of Technical Operations, the Laboratory Director and the Research staff in the resolution of difficult technical problems
• Assign or perform evaluations of new laboratory procedures, modifications to current procedures; ensure SOPs are accurate and current
• Recommend additions or modifications of tests and procedures
• Ensure adherence to laws and regulations pertaining to laboratory inspections, safety and licensure
• Develop and administer orientation, training and proficiency programs for all laboratory staff; mentor and develop staff
• Provide assistance as needed to support field staff, draw sites and customers


Qualifications:
• BS/BA in chemical, physical, biological or clinical laboratory science required; experience with molecular-based testing methods (RNA technologies, PCR, real-time PCR) preferred
• State of California Clinical Laboratory Scientist or appropriate California specialty license required
• Minimum of 5 years laboratory supervision / management experience with increasing responsibilities required
• Must have a solid working knowledge of QA principles, concepts, systems, industry practices, and standards
• Must have working knowledge of applicable local, state and federal safety laws Extensive working knowledge of CLIA, CAP, NY state, HIPAA and other applicable healthcare and laboratory regulations
• Experience with Environmental Health and Safety regulations desirable
• Good understanding of statistical methods and application to the analysis of complex assays
• Strong verbal, technical writing and interpersonal skills are required
• Must be computer literate; proficient in the use of Microsoft Office suite (i.e., Word, Excel, and PowerPoint).


To Apply
Please email your statement of interest and resume to jobs@xdx.com. Please specify which position you are applying for by including the Job Code (TO-07131-W) in the subject line of your email. If possible, submit resume as a Word document. Principals only please.


XDx is an Equal Opportunity Employer.


We are not working with any outside agencies or recruiters in filling this position. If you are interested in the opening, you must apply directly to this ad. We are not accepting calls from any outside agencies or recruiters.