Location Calabasas, California, Calabasas Highlands, CaliforniaJob ID 19-88482
Esoterix Inc., a specialty testing division of LabCorp, is presently seeking an Associate Scientific Director to join the R&D Department in Calabasas, CA. The Calabasas laboratory performs testing for endocrine disorders, rheumatology, gastroenterology, neurology and other specialty medicine fields.
Primary responsibilities of the Associate Director role include;
Oversees scientific and technical direction of the laboratories and manufacturing, including direct responsibility for solving any technical issues
Reviews overall performance of each laboratory, including reported reference ranges and types of reports submitted to clients
Identifies, investigates, and explores the need for new assays, equipment, and processes, finding ways to enhance business performance and opportunities with an awareness of the cost/benefits. Prepares corresponding capital requests
Establishes proper procedures for setup and validation of assays and testing documentation
Assures that the quality of laboratory results is at the highest practical level
Sets efficiency and TAT parameters for the laboratory, determining how these parameters should be monitored.
Provides technical input for Standard Operating Procedures; Reviews and approves final reports, validation plans and validation reports; Documents all activities necessary to ensure regulatory compliance
Consults with clients concerning interpretation and clinical significance of test results
Provide input for marketing literature and assists with sales team training on services offered by Esoterix Inc.
Travel with sales teams as necessary to meet clients and secure new business
Adheres to the standard operating procedures and safety requirements of Esoterix, CLIA, CAP and other regulatory bodies
PhD in biological chemistry, analytical chemistry, or related scientific discipline
Minimum of 5 years of relevant experience in clinical laboratories
Eligible for California CCS or CLS license
Extensive working experience with the following fields and/or methodologies in their application, troubleshooting and methods development:
LC-MS/MS of small molecules and proteins/peptides
Regulated bioanalysis / clinical trials testing
Surface Plasmon Resonance
Robotics and assay automation
License/Certification/Education: Requires a Ph.D. or MD w/6 or more years of Clinical Lab experience. Must meet all licensing as required by CLIA or Director accreditation from a national certifying agency (i.e., SAMSHA formerly known as NIDA).