The Assay Development Scientist advances technology necessary to develop state-of-the-art genomic assays. The scientist plans, organizes, and executes appropriate experiments and laboratory verification and validation work to achieve this goal. The incumbent will train and provide scientific direction to scientific personnel of various levels as needed and be proficient in scientific design and statistical analysis.
Essential Duties and Responsibilities
- In consultation with the clinical Laboratory Director and/or Chief Scientific Officer, as appropriate, initiate experimental design for assay development.
- Conduct assay system development, optimization, verification and validation.
- Under licensed supervision, run experiments to evaluate new laboratory instrumentation and equipment for laboratory testing in cooperation with the equipment manufacturer.
- Prepare technical SOPs as required for Laboratory Director review and approval.
- Prepare assay validation reports and other assay-related documentation as defined by the Laboratory Director.
- Work closely with informatics personnel to support their work in development of algorithms, computer programs, databases, etc., as required for assay execution, automation and data management.
- Under licensed supervision, assist, and/or coordinate technical transfer of new assays and procedures to clinical laboratory.
- Under licensed supervision, assist, as needed, in the training of lab personnel on new procedures.
- Provide scientific supervision and guidance, as appropriate, in the routine execution of their laboratory work.
- Keep Laboratory Director and/or CSO informed about status of ongoing projects.
- Prepare written and oral presentations of scientific updates for presentation at R&D meetings and conferences.
- Maintain awareness of current and developing technologies.
- Interact with outside sources of emerging technologies, science and materials.
- Comply with industry regulatory and quality standards.
- Assist licensed supervisor and technologists with troubleshooting, including reviewing procedural execution for possible root cause of out-of-control results. Designs and executes troubleshooting procedures and performs R&D problem-solving experiments.
Physical Demands and Environmental Conditions
- Regularly walks, stands, and sits
- Regularly works with equipment, tools and on a computer
- Must follow laboratory safety practices when working with, for example, hazardous materials including use of personal protective equipment such as gloves, lab coats, and safety glasses
- Must be able to read and understand scientific and complex directions