Research Scientist II

Summary of Major Responsibilities:

The Research Scientist II, with limited guidance from more experienced scientists, works individually and in collaboration with others on multiple projects which are moderate to complex in scope. The Research Scientist II plays an active role or leads in the 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 of the project. Working in a team setting, the Research Scientist II will be involved in Research and Development projects serving as a technical lead or a subject matter expert in translating research ideas and concepts into the product development pipeline towards development of diagnostic assay products.

The Research Scientist II position will conduct benchwork experiments that include performing and analyzing data from assay and methods development. Responsibilities include development and verification & validation testing required for liquid biopsy-based pipelines and products. This position will require strong proficiency in molecular and cellular biology, and implementation of statistical software analyses. The Research Scientist II position necessitates the responsibility for projects implemented by the phase-gate development of blood-based assays and devices for diagnostic use.

• Conduct bench level experiments within several product or technology areas and identify problems and discrepancies.
• Independently 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.
• Operate scientific instrumentation related to performance of duties and notify appropriate personnel of any problems.
• Effectively utilize and apply methods or technologies and provides 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.
• 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 the analysis or summarization of experimental results, outcomes, and next steps to supervisor, technical teams/groups, or project teams.
• Present experimental results and defend scientific ideas and findings at project or departmental meetings, lead meetings as subject matter expert.
• Work on problems of diverse and complex in scope in which analysis of data requires in-depth evaluation of identifiable factors.
• Exercise judgment within broadly defined practices and policies in selecting 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 moderate to 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.
• Assist in planning and recommendation of activities that account for prioritization of organizational and department goals.
• Ability to train and mentor research associates.
• Ability to organize, present, and convey moderate 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 proficiency, 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 companys 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 5% 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 Masters 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 a PhD; or Bachelors 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.
• 3+ years of industry or academia experience in biology and/or chemistry.
• 2+ years of experience in medical device/IVD, biotech, life science, or pharmaceutical industry.
• Demonstrated ability to apply molecular biology and/or biochemical techniques.
• Proficient in the principles of molecular biology and/or biochemistry and/or next-generation sequencing (NGS) and genomics.
• Demonstrated understanding of GMP, ISO, and Quality Systems.
• Familiarity with product/assay research, design, or development.
• Basic 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, 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

• 4+ years of assay development and/or industry experience molecular and cell biology.
• Proficient with various molecular biology and/or biochemical platforms, tools and systems.
• Experience with automated liquid handlers for blood processing.
• Experience in an LDT- or FDA-regulated environment in medical device development.
• Experience in a biotech manufacturing environment, preferably in an GMP and/or ISO environment.
• Previous experience working in a molecular diagnostics/clinical laboratory setting.

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Companys affirmative action program are available to any applicant or employee for inspection upon request.