Sr. Research Scientist

Abbott • San Diego, CA

1d • $114,000 - $228,000 • Onsite

About The Position

This position works out of our La Jolla location in the Cancer Diagnostics Division. As the Sr. Research Scientist, you’ll have the chance to lead verification and validation studies for innovative NGS-based multi-cancer early detection solutions that improve clinical test access, quality, and performance for patients.

Requirements

• 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.

Nice To Haves

• 8+ years of industry or academic research experience in Life Sciences, Chemistry, or a related field, ideally with hands-on experience developing, optimizing, and troubleshooting NGS-based workflows for clinical DNA/RNA samples
• Proficient in NGS data analysis and interpretation, statistical/mathematical methods in biology and genetics (e.g., JMP), and experience with product development in an LDT- or FDA-regulated environment.

Responsibilities

• Drive verification and validation studies to support molecular test product launch in CAP/CLIA clinical laboratory and regulatory submission, including but not limited to: PMA (Pre-market approval) and IDE (Investigational Device Exemption)
• Lead cross-functional study design discussion, working closely with multiple departments such as biostatistics, bioinformatics, regulatory, medical director, quality and clinical lab operations
• Serve as technical lead conducting and analyzing NGS experiments across multiple product and technology areas
• Design and optimize NGS-based solutions that integrate clinical product requirements with analytical and operational performance
• Mentor and provide technical guidance to junior scientists and research associates
• Present experimental results and defend scientific findings at data, group, and project team meetings
• 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.
• 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.
• 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.
• 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.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree