Sr. Scientist - Contract

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. Present experimental results and defend scientific ideas and findings at data meetings, group meetings, and project team meetings and/or departmental meetings lead meetings as subject matter expert.

Title: Sr. Scientist
Location: La Jolla CA  92037
Duration: 3+ Months contract 
Shift Details: 09 AM - 05:00 PM 

Description:

DO WORK THAT MATTERS
Diverse ideas, perspectives, and expertise allow us to create life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals,  offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

As a Sr Research Scientist Contractor, 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. 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.

RESPONSIBILITIES
Include, but are not limited to, the following:

Lead select 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 for the study you own, working closely with multiple departments such as biostatistics, bioinformatics, regulatory, medical director, quality and clinical lab operations
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.
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 lead 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.
Mentor and provide technical guidance to junior research associates
Present experimental results and defend scientific findings at data, group, and project team meetings
Integrates project results into broader research objectives; prepares and reviews technical reports and presents findings to project teams and leadership.
Contributes to protocol/procedure development, process improvement, and relevant regulatory compliance and quality standards.
Effectively collaborates with multidisciplinary teams across projects, ensuring alignment with business and scientific goals.
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.
Ability to lift up to 25 pounds within the 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 complete fine finger manipulation (e.g., picking, pinching, etc.) and twisting at wrist motions 50% of a typical working day.
 

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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