Scientist III - Assay Development

The Esoterix division of Labcorp is seeking a Scientist III to join its R&D Assay Development team in Calabasas, CA. Esoterix provides esoteric testing for hospitals and physician specialists and pharma clients primarily specializing in Endocrinology, Rheumatology and Rare Disease testing. Esoterix provides premier laboratory services that positively impact patient care and cost-effective medical treatment.

As an advanced scientific contributor in the R&D department, Scientist III PhDs evaluate, propose, and develop new tests and enhance current tests. This position will design and develop new assays, analyze and evaluate data, develop and introduce new techniques and conduct other R&D functions as needed. This Scientist III position will focus on the development of RIA, ICMA, ELISA and other methods focusing on Peptides and large molecule assay development.

• Performs data analysis, writing of scientific abstracts, posters, and publications.
• Supervises direct reports on R&D activities such as experimental design and review and analysis of work performed.
• Maintains schedule of projects and timelines. Coordinates research activities to ensure efficiency and quality.
• Communicates project timelines, status, data, reports, effectively addressing any issues that may arise.
• Works with pharma and academic clients to design and develop new assays or method transfers.
• Works with operations directors to implement method transfers.
• Works with QA to prepare paperwork for NY and other regulatory agencies.
• Works with vendors to set-up new product lines such as antibodies and other unique supply needs
• Leads effort in development and implementation of new diagnostic assays and processes, as well as modifying current assays and troubleshooting various assay procedures.
• Writes validation plans, conducts testing for validation, and writes validation reports for assays and diagnostic kits.
• Set-ups, utilizes, and maintains complex instrumentation.
• Maintains lab notebook and raw data binder and obtains sign off as appropriate.
• Creates or updates SOPs when assays are modified or created.
• Assists with assay automation, MOLIS interface and reagent preparation protocols.
• Manages launch of new assay and implementation of assay changes providing hands on training
• Reviews reports from R & D team prior to submission to Quality Assurance.
• Manages R & D resources including refrigerators and freezers, lab areas and equipment.
• Manages temporary utilization of non R&D personnel for R&D projects.
• Provides operational support on non-routine non reoccurring basis to troubleshoot assay methodology.
• Research literature and external sources and identify new techniques and procedures.
• Participates in scientific meetings as requested and present data.
• Adheres to the standard operating procedures and safety requirements of Esoterix, CLIA, CAP and other regulatory bodies.
• Documents all activities as necessary including preventative maintenance logs, instrument function checks, troubleshooting, and quality control to ensure regulatory compliance.
• Follows any other job-related instructions and performs any other job-related duties requested by department management.

• PhD in Biology, Chemistry, or similar scientific discipline required
• CA CLS Generalist license preferred, not required
• Minimum 5 years of relevant laboratory experience
• Previous R&D experience preferred
• Experience with ELISA, RIA, ICMA and Routine analyzers
• Experience with robotic liquid handling systems a plus
• Ability to exercise independent judgment to determine methods and procedures on new assignments.
• Good understanding of CAP/CLIA/ NY validation requirements
• Meticulous with strong troubleshooting capabilities
• Proficient computer skills including Microsoft Office Word, Excel, and PowerPoint