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Research And Development Scientist - Molecular Biology

Employer
Shield T3 LLC
Location
Chicago, Illinois, US
Salary
Competitive
Closing date
Sep 29, 2022

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Shield T3 Research and Development Field Scientist, Molecular Biology - 20% travel required

Shield T3 Health is a mission-based molecular diagnostics company that provides high-quality low-cost COVID19 diagnostics, and molecular microbiology testing. We provide our clinical testing services through our CLIA-accredited laboratories that are currently located in Sunnyvale and Claremont in CA, Washington, DC, Georgetown, KY, Orono, ME, and Madison, WI, and rapidly expanding to other locations. For more information, visit https://www.shieldt3.com/

We are rapidly expanding into other areas of healthcare and clinical diagnostics testing. We are looking for a versatile molecular biology scientist to develop the technology necessary to develop state-of-the-art assays for microbiology, infectious diseases, epidemiology, genetics, genomics, and oncology with a special focus on PCR-based genotyping and next-generation sequencing-based laboratory-developed assays or IVD products. This professional will plan, organize and implement basic experiments to achieve this goal. The Molecular Diagnostics Scientist will also provide scientific design and statistical analysis.

This role is based in Chicago, IL. A 20% travel is required within the United States to perform R&D experiments, and field clinical validations at various Shield T3 laboratories.

Position Summary
  • A highly motivated early career researcher with strong quantitative skills. You will have completed a Ph.D. In molecular biology or related biology field and have a minimum of one year of molecular diagnostics experience with a proven track record of developing Laboratory developed tests and IVD products from scratch.
  • The R&D Scientist works under the guidance of a Manager/Senior Scientist/Lab Director/CSO to execute verification and validation studies, under design control, for PCR-based or next-generation sequencing (NGS) assays to support regulatory submissions. Works hands-on at the bench to carry out experiments and studies with minimal guidance.


Primary Responsibilities:

  • Initiate experimental design and feasibility studies for assay development.
  • Independently plan, direct and execute experimental strategies to meet regulatory agency requirements.
  • Conduct assay system development, optimization, and validation studies.
  • Run experiments to evaluate new laboratory instrumentation and equipment for laboratory testing in cooperation with the equipment manufacturer. Anticipate potential problems and design preventative solutions. Determine a strategic approach to experimental design.
  • Manage a group of technologists or junior scientists for assay development and validations.
  • Prepare technical SOPs as required for the Manager/Senior Scientist/Lab Director/CSO/CMO's review and approval.
  • Prepare assay validation reports and other assay-related documentation as defined by the management.
  • Work closely with informatics personnel to develop computer programs and databases as required for assay execution, automation, and data management.
  • Under supervision assist and/or coordinate the technical transfer of new assays and procedures to the appropriate department.
  • Assist, as needed, in the training of lab personnel on new procedures.
  • Provide scientific supervision and guidance to research associates in the routine execution of their laboratory work.
  • Keep Manager/Senior Scientist/Lab Director/CSO informed about the status of ongoing projects.
  • Prepare written and oral presentations of scientific updates for presentation at R&D meetings and conferences.
  • Maintain awareness of current and developing technologies.
  • Interact with Academic Associates and other outside sources of emerging technologies, science, and materials.
  • Add input to annual review for research personnel supervised while working on special projects.
  • Complies with industry regulations and quality standards for the R&D Assay Design Control processes. Ensure technical activities are conducted following Shield T3's Quality Management System and aligned with broader regulatory requirements (CLIA/FDA).
  • Assists licensed supervisor with troubleshooting, including reviewing procedural execution for the possible cause of out-of-control results. Carries out simple troubleshooting procedures and performs R&D problem-solving experiments as instructed.
  • Responsibilities include working with infectious materials and supporting and complying with the company's hazard waste handling practices.
  • Identifies problems investigates alternatives and recommends possible courses of action.
  • Maintains knowledge of technological developments that may assist in the completion of an assignment or lead to new products, processes, or procedures by reading current literature.
  • Effectively utilizes and applies advanced methods or technologies.
  • Should be willing to travel to other Shield T3 locations, and help production teams if necessary.
  • Contributes ideas for new product development typically within existing markets.


To qualify, the ideal candidate will have the following skills and experience:

  • BS/BA in Biology, Molecular biology, Biochemistry, or related field required. Higher degree preferred.
  • 8+ years of relevant industry molecular diagnostics experience in research and development in a CLIA/CAP/FDA regulated laboratory for candidates with a BS/BA degree; 4+ years of industry experience for candidates holding an MS/MA degree, or a Ph. D. in molecular biology, biochemistry, or related field with a minimum 1-year industry experience.
  • Proven track record in developing Laboratory developed tests, IVD products, or with a focus on molecular assays and systems.
  • A deep understanding of qPCR, RT-qPCR, and PCR reaction dynamics. Demonstrated experience with qPCR optimization, PCR primer/probe design, and DNA sequencing.
  • Industry experience in developing and launching novel assays and products is a plus.
  • Ability to read and interpret documents such as professional journals, operating instructions, and procedure manuals.
  • Ability to write complete reports, SOPs, and correspondence.
  • Ability to speak effectively in one-on-one and small group situations.
  • Ability to apply mathematical concepts to problem-solving situations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, and correlation.
  • Solid skills with Microsoft Office products - Word, Excel, PowerPoint, and Outlook.
  • Clinical Laboratory Training or Laboratory Scientist Licensure is not required but a plus.
  • Proven ability to accomplish technical tasks both independently and as a member of a research team.
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