Senior Scientist, Molecular POC
Job Description SummaryThe Sr. Scientist works within a team that develops new point-of-care assays for human in vitro diagnostic use, using nucleic acid isolation, amplification, and detection technologies. Assists in the design, development, integration, and qualification of assays and/or specimen processing workflows. The associate applies laboratory, scientific, and analytical skills to plan and execute experiments and find creative solutions to technical challenges. Works with minimal supervision under the general guidance of Staff Scientists, or Sr. Staff Scientists.
Duties and Responsibilities:
- Utilizes a broad range of practical techniques in molecular biology, microbiology, and chemistry.
- Prepares and maintains bacterial and viral cultures, and performs quantitation of organisms for downstream experimental use.
- Plans and executes experiments and large-scale multi-experiment studies.
- Develops and/or adapts procedures to meet specific objectives and solve problems.
- Analyzes and interprets data.
- Summarizes results in written and oral reports for departmental and interdepartmental reviews and/or for external publication.
- Writes and executes protocols for formal verification under Design Control.
- Supervises the work of Scientist I and Scientist II associates, and assists in development and performance reviews.
- Interfaces with other facilities and corporate partners to facilitate product development.
- Is responsible for the maintenance of complex laboratory equipment and facilities.
- Maintains current knowledge of major technological and scientific developments in molecular diagnostics, and leverages this knowledge within responsibility areas.
- Might assist with product quality investigations.
- Might also provide support in execution of clinical studies to validate system performance and assemble data in support of regulatory submissions.
Knowledge and Skills:
- Skilled with a variety of complex laboratory procedures and experimental and analytical methods.
- Demonstrated ability to learn new scientific and technological approaches.
- Working knowledge of scientific method, experimental design, data analysis, and results interpretation. Understanding of the theory of measurement, sources of error, and comparative advantages of different methodologies.
- Proficiency in a range of techniques in molecular biology including nucleic acid extraction and amplification is required. Meticulous technique in handling of nucleic acids is required.
- Demonstrated ability to work effectively within a team, under direction, and independently.
- Excellent oral and written communication skills.
Education and Experience:
- Minimum of Master’s degree in Molecular Biology, Chemistry, Biochemistry, Bio/Biomedical Engineering, or related discipline – or equivalent combination of education and experience.
- Minimum of 4 years of directly relevant experience in clinical assay development or related field.
- Work experience in a laboratory requiring meticulous technique in the handling of nucleic acids.
- Experience in processing clinical specimens for the recovery of nucleic acids, together with a strong background in microbiology, virology, and/or clinical laboratory science is preferred.
- Experience with growth and enumeration of bacteria and viruses is preferred.
- Experience in diagnostic product development under Design Control is preferred.
- Experience handling infectious biological samples and working in a cGMP environment are preferred.
Primary Work LocationUSA CA - San Diego (Diagnostic Sys.)
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