12 Jun
Immunoassay Scientist - Calabasas, CA
Vacancy expired!
- 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.
- 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
- Working independently develops new assays and modifies current assays including research and bench level testing.
- Writes validation plans, conducts testing for validation, and writes validation reports for assays and diagnostic kits.
- 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.
- 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.
Vacancy expired!