Basic Function and Scope of the Position
DS is responsible for implementing company protocols in laboratory experiments. It is their job to ensure that product research and development is performed in a manner that complies with applicable regulations and industry standards.
- Supports development projects, which can include generating analytical data for an FDA submission.
- Designs, leads execution of, and documents highly complex experiments that support the development of diagnostic reagents and assays. Experimental design will include all of the appropriate controls. Assists with writing study protocols and reports, which may be auditable.
- Writes and finalizes protocols and reports according to standard guidelines when they are available. May publicly present study results. Responsible for accuracy and completeness of auditable documents.
- Maintains a laboratory notebook that records all aspects of experimental design and results. Reviews laboratory notebooks of lower level direct reports. When applicable, maintains electronic copies of experiments, procedures, instructions, data, and analysis in appropriate locations.
- Uses laboratory techniques such as preparation of buffers and media, aseptic technique, cell culture, specimen processing, nucleic acid isolation and manipulation, PCR, and gel and capillary electrophoresis.
- Independently operates laboratory equipment such as thermocyclers, next generation sequencing platforms, spectrophotometers, fluorometers, centrifuges, cell counters, autoclaves, scales, and DNA isolation workstations.
- Performs data analysis using available software such as Microsoft Excel, JMP, and GeneMapper.
- Ensures that laboratory reagents are properly stocked, equipment is maintained, and that laboratory bench is clean and clutter-free.
- May support project Core Team and Design Review activities.