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Staff Scientist, R&D
Job Description
Purpose of the Position:
Plan, perform and analyze the results from scientific experiments leading to the invention, design and development of oligonucleotide probe tests for in vitro diagnostic use . Prepare protocols, reports, Work Instructions and other written materials that meet Quality System requirements. Develop technical solutions to product design and performance issues. while meeting ISO and FDA regulatory and design control requirements.
Essential Functions:
•Work under the direct supervision of R&D management to achieve technical objectives within the scope of the overall project.
•Identify and test potential solutions to defined project issues based on scientific knowledge, evaluation of the scientific literature, and laboratory research
•Develop and validate new genomic assays.
•Perform experimental studies to establish the design of oligonucleotide probes, primers and multiplex assays products .
•Design protocols and perform experimental studies to evaluate the performance of prototype products relative to product performance and customer requirements.
•Analyze data, evaluate results, form conclusions, and provide and/or implement product, process, or documentation improvements.
•Design experiments to be performed by Research Associate-level employees; analyze data resulting from these experiments.
•Document experimental protocols, results of studies and product design/development history in the form of laboratory notebook entries, written reports and/or company presentations. Documentation must be clearly understandable to the target audience and must meet ISO standards, FDA QSR requirements and/or protection of company intellectual property.
•Work closely with team members in a collaborative environment.
•Develop work plans and approaches to deliver results as efficiently as possible.
•Adjust work schedule meet time-sensitive project milestones.
Education:
An M.S. Degree in Biochemistry, Microbiology, Molecular Biology or a related field and 3 years relevant experience. Alternatively, a Ph.D. Degree in one of these fields.
Experience:
•Previous experience working in a commercial setting required.
•Demonstrated ability to solve complicated problems.
•Prior experience working in a QSR-compliant environment .
•Prior experience in developing and commercializing new products.
Company
DxTerity Diagnostics
Job Code
State or Province
California
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