Research Scientist II, Tech Transfer - Thrive
Full Time
Cambridge, MA
Posted
Job description
Position Overview
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 in planning of projects and experiments and is often the technical lead responsible for the successfully transferring and supporting assays. This position involves independently making detailed observations, analyzing data, interpreting results, and training laboratory staff on new and updated procedures. Working in a team setting, the Research Scientist I, will primarily be involved in Research and Development projects serving as a technical lead and liaison to ensure developed procedures for diagnostic assay products are optimized for all aspects of the operations environment.
The Research Scientist II, as a member of Design Transfer & Applications Support, will work closely with a cross-functional team to ensure timely technology transfer of laboratory assays, from development to operations, and provide technical support of ongoing production and reagent manufacturing in accordance with regulatory guidelines. This role will work closely with other Product Development scientists and engineers to integrate assays with production environments, execute validation and qualifications studies, and provide technical support to identify and help resolve laboratory issues.
Essential Duties
Include but are not limited to the following:
- Establish a bridge between PD and clinical lab operations across three critical functions: (1) technology transfer of new and/or optimized clinical lab assay workflows, (2) support for ongoing production such as, troubleshooting, CAPAs, etc., and (3) support for reagent formulation and quality control.
- Maintain a highly collaborative and service-oriented partnership with the clinical lab operations and technology teams to enable technology transfer and applications support.
- Support technology transfer of assay and reagent production workflows from product development to operations; including, but not limited to, support systems integration, assay optimization, and user training, execution of assay qualifications, such as, IQ, OQ, and PQ, and analytical validation studies.
- Support the development of materials management procedures to include purchasing specifications, formulation of standard operating procedures (SOPs), and reagent quality control methods for CLIA and QSR laboratories.
- Provide timely, technical, and scientific support to operations teams to help track, assess, and resolve any incidents and/or non-conformance issues that may arise during sample processing and reagent production according to our quality policy.
- Follow design and process change control procedures to include risk assessments, escalation to product development and technology teams, and implementation of revised procedures according to change control best practices.
- Work with a cross-site team of applications and development scientists to support product and operational requirements; including, but not limited to, quality control of reagents, laboratory processes, test methods, and calibration/preventative maintenance routines.
- 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.
- Prepare and provide information and data for scientific abstracts/conferences/project meetings/publication.
- Generate, document, and communicate training and technology transfer plans for critical aspects of a project.
- 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 review written reports.
- Support 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 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.
- 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 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 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 20 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 a 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.
- 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.
- Comfortable in a fast-paced, dynamic team environment.
- 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
- Experience in writing SOPs and research reports
- 1+ years experience training laboratory staff on moderate to complex processes in a regulated laboratory
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If you need any assistance seeking a job opportunity at Exact Sciences, or if you may require a reasonable accommodation with the application process, please email
hr@exactsciences.com
.
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 Company’s affirmative action program are available to any applicant or employee for inspection upon request.
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