Job Description
Job Summary:
- The individual will work with R&D on product development, and analytical validation workflows.
Duties and Responsibilities:
- Will apply technical knowledge to develop design verification and validation test methods. kits/reagents/instruments/workflows for nucleic acid purification from plasma, cell culture media and FFPE samples.
- Using automated technology to extract Nucleic acids from diverse sample types.
- Modify experimental procedures to suit the particular needs of experiments.
- Develop a hypothesis and then design the necessary set of experiments to test the hypothesis with limited guidance.
- Analyze the data derived and explain the outcome of their experiments.
- Maintain accurate and detailed lab notebooks and appropriate documentation based on the scientific method enabling other scientists to reproduce their experiments.
- Prepares regular reports documenting experiments.
- Presents research data and conclusions in 10-30 minute sessions.
- Ability to read a scientific paper, reproduce the experiments described and understand the conclusions.
- Complete lab compliance activities.
Education and Experience:
- Bachelors or Masters degree in Biological Science, chemistry, biochemistry, biomedical engineering or related field.
- At least 3-5 years laboratory experience in either academic or industry setting.
- Industrial experience in Next Generation Sequencing environment a plus.
- Regulated background experience a plus.
- Experience with statistically-based plan development, power, test method development, data-driven decision-making, statistical analysis (JMP), DOE, and design-focused six sigma experience.
- Experience in an IVD development environment.
- Experience writing and implementing quality focused procedures.
- Experience working with BSL2 sample types in BSL2 lab setting.
Knowledge, Skills and Abilities:
- Mammalian cell culture experience is a plus.
- Technical expertise in molecular biology and standard analytical QC assays.
- Specifically, automated and manual nucleic acid isolation techniques, qPCR, dPCR, and NGS using Applied Biosystems and Client instrumentation: Kingfisher Magnetic Particle Handlers, Quant studios, Ion Torrent, Nanodrop, Qubit, etc.
- Good writing & presentation skills.
- Works well in a team setting, flexible, highly collaborative, ready to learn, and always willing to help others
- Capable of multi-tasking and ensure timely completion and execution of tasks.
- Self-motivated, detail oriented, proactive, organized, diligent, and flexible.
- Shows initiative by taking on new tasks, beyond what is generally expected.
- Generates ideas to improve current processes.
- Strong knowledge of Microsoft Office Suite, specifically Word, Excel, PowerPoint.
Strong laboratory and technical hands on skills required:
- Pipet and perform procedures reproducibly.
- Perform a dilution series to create a standard curve.
- Perform lab calculations needed to make solutions from powder or from stock.
- Operate basic lab equipment such as computers, centrifuges, quantitation instruments, Agilent Bioanalyzer, PCR, real-time qPCR instruments, plate readers etc.
- Routine experience with most common molecular procedures such as nucleic acid isolation, endpoint PCR, real-time PCR.