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Position Summary:. The Scientist will create, validate, and perform test methods that comply with regulatory standards for products moving through the development process. Products may include buffers, devices, and instrumentation intended for the Clinical IVD market.

Job Responsibilities / Requirements: The individual will work with R&D, Marketing, Operations, and Project Management on product development, test method validation, and design verification and validation of new products.

Required responsibilities:

• Will apply technical knowledge to develop design verification and validation test methods kits/reagents/instruments/workflows for nucleic acid purification from various sample types such as whole blood, plasma, viral transport media, saliva, tissues etc.
• 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

Skills and attributes:

• 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 solutions and able to make the buffers from recipes
• 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
• 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, Quantstudios, Ion Torrent, Nanodrop, Qubit, etc.
• Experience with statistically-based plan development, power, test method development, data-driven decision-making, statistical analysis (JMP strongly preferred), DOE, and design-focused six sigma experience are highly desirable
• Experience in an IVD development environment
• Experience writing and implementing quality-focused procedures
• Experience working with BSL2 sample types in a BSL2 lab setting
• 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

Knowledge, Skills, and Experience

• Bachelors or Masters degree in Biological Science, chemistry, biochemistry, biomedical engineering, or related field.
• At least 3-5 years of laboratory experience in either academic or industry setting. Industrial experience in product development environment a plus.
• Strong knowledge of Microsoft Office Suite, specifically Word, Excel, Powerpoint