Description
Purpose of the Position:Plan, perform and analyze the results from scientific experiments leading to the design and development of genomic probe tests for in vitro diagnostic use based on the Diagnostic technologies. 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 and business objectives within the scope of the overall projects.
- Identify, test, and implement solutions to defined technical and project issues based on scientific knowledge, evaluation of the scientific literature, and laboratory research.
- Develop and validate new genomic assays based on proprietary technologies.
- Perform laboratory studies to establish the design of multiplex molecular assays in order to meet project schedules.
- Design protocols and perform and lead experimental studies to evaluate and document 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 and direct experiments to be performed by Research Associate-level employees; analyze and communicate 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 meet ISO standards, FDA QSR (SOPs, WI, etc.) requirements and/or protection of company intellectual property requirements.
- Prepare product development deliverables per design control policy.
Experience:
- Previous experience working in a commercial IVD product development setting is highly preferred.
- Demonstrated ability to solve technical problems in an assay development and test validation environment.
- Prior experience working in a QSR-compliant environment required.
- Prior experience in all aspects of developing and commercializing new clinical molecular diagnostic products a plus.
- Experience in developing and using new laboratory automation, and molecular biology methods desirable.
Key knowledge includes:
- Broad knowledge of molecular biology and genomic analysis methods.
- In depth knowledge of RNA analysis methods.
- Advanced technical writing skills to produce reports and QSR documents.
Education:
A Ph.D. in Biochemistry, Microbiology, Molecular Biology, or a related field and 3-5 years relevant experience, preferably in the clinical diagnostic products industry. Alternatively, an M.S. degree in one of these fields and 5+ years of relevant industrial experience will be considered.
To find out more about Real please visit www.realstaffing.com