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Position Overview
The Sr. Research Scientist I, with input from senior scientists and leaders, works in collaboration with others on one or more projects which are complex in scope. The Sr. Research Scientist I participates in or leads planning of projects and experiments, and is often the technical lead responsible for the successful execution of the project. This position involves independently making detailed observations, analyzing data, interpreting results and providing insights into the next steps and direction of the project, as well as independently determining methods and procedures on new assignments or projects.
Working in a team setting, the Sr. Research Scientist I will be involved in Research and Development projects serving as a technical lead and/or a subject matter expert in exploring and researching new technologies, providing ideas and concepts to improve or develop processes, and/or establish methods and processes for product development towards development of diagnostic assay products. This position will also mentor and provide technical guidance to junior scientists in project teams.
This position is onsite in San Diego.
Essential Duties
- Conduct bench level experiments within several product or technology areas and identify problems and discrepancies.
- Independently develop, plan, and analyze results of bench level experiments within several product or technology areas; effectively present and clearly communicate findings at data meetings, group meetings and project team meetings.
- Analyze research/experimental data, interpret the results, and provide insights into the next steps and the direction of the project.
- Independently develop methods and procedures for new assignments/study/experiments.
- Provide technical guidance to junior scientists in project teams.
- Operate scientific instrumentation related to performance of duties and notify appropriate personnel of any problems.
- Effectively determine, utilize, and apply methods or technologies and provide ideas for new techniques, when appropriate.
- Maintain knowledge of technological industry developments that could assist in completion of an assignment or aid in the development of new processes or procedures.
- Provide technical input and participate in decisions affecting project planning and experimental design.
- Prepare and provide information and data for scientific abstracts/conferences/project meetings/publication.
- Contribute to the intellectual property portfolio by implementing innovative and creative ideas to solve problems or improve on current methods.
- Generate, document, and communicate development plans for critical aspects of a project.
- Develop research plans and experimental outlines to write experimental protocols and perform laboratory experiments.
- Prepare detailed technical procedures, protocols, and reports.
- Evaluate impact of nonconforming data to product or process.
- Identify and address trends in study data.
- Prepare and approve written reports.
- Lead identification of areas for process improvements.
- Maintain lab notebook in a clear, complete, and consistent manner, following all legal, ISO, and QSR requirements.
- Prepare reports and documentation providing highly technical analysis or summarization of experimental results, outcomes, next steps, and the future direction of the project to functional leader, technical teams/groups, or project teams.
- Present experimental results and defend scientific ideas and findings at data meetings, group meetings, and project team meetings and/or departmental meetings as subject matter expert.
- Work on problems which are extremely complex in scope in which analysis of data requires an evaluation of intangible variables.
- Exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining solutions.
- Work on individual assignments and with project team members, as appropriate, to meet department and project objectives.
- Work within project timeframes with successful outcomes on multiple projects and key responsibilities.
- Act as technical leader for one or more projects that are complex in scope.
- Act as subject matter expert in core team and/or cross-functional meetings.
- Exercise discretion and independent judgement within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining and interpreting results, analyzing data, and presenting findings in a professional and knowledgeable manner.
- Promote an open, collaborative environment built on trust to foster positive teamwork.
- Plan and recommend activities that account for prioritization of organizational and department goals.
- Train, guide, and mentor research associates and junior level Scientists.
- Organize, present, and convey complex problems or issues.
- Ability to communicate clearly and frequently with all levels of the organization; including team members, project team members (core and extended), functional managers, clinical lab, and other stakeholders.
- Create high quality presentations that effectively communicate and tie into a cohesive story the project status and/or experimental results.
- Apply strength in performing complex analyses and the ability to present data and recommendations to a variety of audiences throughout an organization.
- Apply qualitative and analytical skills with strong attention to detail.
- Ability to effectively work on several varied projects at one time, with frequent changing priorities.
- Excellent analytical, problem solving and decision-making skills.
- Apply technical expertise, scientific creativity and rigor, collaboration with others and independent thought; ability to provide insights and defend scientific ideas.
- Apply experimental knowledge and outcomes to new and valuable problems; ability to make predictions based on a deep understanding of the fundamental nature of the inputs into a decision or action.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company's Quality Management System policies and procedures.
- Regular and reliable attendance.
- Ability to lift up to 20 pounds for approximately 5% of a typical working day.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 50% of a typical working day.
- Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
- Ability to comply with any applicable personal protective equipment requirements.
- Ability to use various types of laboratory equipment including microscopes, microtomes, blades, strainers, and pipettes for extended periods of time.
- May perform repetitious actions using lab tools.
- Ability to use near vision to view samples at close range.
- May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
- Ability and means to travel between local Exact Sciences locations.
- Ability to travel 10% of working time away from work location, may include overnight/weekend travel.
Minimum Qualifications
- PhD in life sciences, medical technology, clinical laboratory science, chemical/physical/biological science, or related field; or Master's degree in life sciences, medical technology, clinical laboratory science, chemical/physical/biological science, or related field and 4 years of related experience in lieu of PhD; or Bachelor's degree in life sciences, medical technology, clinical laboratory science, chemical/physical/biological science, or related field and 6 years of related experience in lieu of PhD.
- 5+ years of industry or academia experience in biology and/or chemistry.
- 3+ years of experience in medical device/IVD, biotech, life science, or pharmaceutical industry.
- Demonstrated ability to apply molecular biology and/or biochemical techniques.
- Demonstrated understanding of GMP, ISO, and Quality Systems.
- Technical expert in the area of molecular biology and/or biochemistry and/or next-generation sequencing (NGS) and genomics.
- Good knowledge of product/assay research, design, or development.
- Basic working knowledge of statistical and mathematical methods in biology/genetics, including experience with statistical software, such as JMP.
- Proficient computer skills to include Internet navigation, Email usage, and word processing.
- Proficient in Microsoft Office to include Excel and Word and PowerPoint.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Authorization to work in the United States without sponsorship.
Preferred Qualifications
- 8+ years of industry or academic research experience in Life Sciences, Chemistry, or related field.
- 6+ years of experience in medical device/IVD, biotech, life science or pharmaceutical industry.
- Experience in a pharmaceutical or biotech manufacturing environment, preferably in a GMP and/or ISO environment.
- Experience with genomic databases and related software.
- Previous experience working in a molecular diagnostics/clinical laboratory setting.
- Deep understanding of the practices and principles of NGS including molecular biology and data analysis based upon extensive hands-on experience with the development, optimization and troubleshooting of NGS-based workflows for DNA and RNA from clinical samples.
- Extensive experience with interpretation and analysis of NGS data using external and in-house computational methods to support method development and characterization of genomic and epigenomic biomarkers associated with cancer.
- Experience with product development for use in an LDT- or FDA-regulated environment including designing analytical validation studies, ideally in medical device development.
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