Researcher I - Silver Spring, United States - Kikiktagruk Inupiat Corporation

Mark Lane

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Mark Lane

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Description

Title:
Researcher I


Location:
Silver Spring, MD


Status:
Full-Time


Position Summary:

Midnight Sun Technologies is looking to hire a Researcher I.


A primary mission at FDA's Center for Biologics Evaluation and Research is to protect and advance public health by ensuring the safety and efficacy of biotherapeutics, including gene therapies and cell therapies.

To support this mission, the Division of Cellular and Gene Therapies (DCGT) within the Office of Tissues and Advanced Therapies (OTAT) is working on developing methods and tools for evaluating safety of gene and cell therapy products involving genome editing technology.


At present, issues of gene and cell therapy safety assessment include: (i) a lack of physiologically relevant cellular system that can evaluate side effects of genome editing tools on genome and epigenome, (ii) demand for in vitro cellular assay to determine effect of editors on stem cell differentiation and proliferation, (iii) demand for development of robust and sensitive in vivo assays of RNA editing.

This work will help address these issues by developing a stem cell-based method for detecting unintended genome and transcriptome modifications following expression of genome editing tools, as well as in vitro and in vivo assays for understanding biological consequences of the unintended modifications.

Developing this methodology will facilitate qualification of safety evaluation tools for developing genome editing-based advanced therapy products.


Duties/Responsibilities:


  • Have a scientific training in Molecular Biology, Biomedical Engineering or related discipline.
  • Have research experience in stem cell biology
  • Have hands on experience in flow cytometry
  • Perform, with technical independence, basic and advanced flow cytometry procedures such as instrument start up and performance characteristics, cell staining, sample acquisition.
  • Be proficient in human stem cell culture
  • Be proficient in fundamental biochemical and molecular biology techniques such as Western Blot, quantitative PCR, DNA and RNA isolation
  • Have in depth understanding of human stem cell biology
  • Have experience in common cellular and molecular assays such as apoptosis, cell cycle, cell proliferation assays
  • Independently plan experiments and process data in Data Analysis and Graphing Software
  • Regularly review relevant/emerging literature, incorporate appropriate concepts, techniques and knowledges into the experimental work
  • Summarize progress for presentation at laboratory meetings and at research conferences, and submit results for publication in a peerreviewed scientific journals
  • Maintain thorough and complete governmentowned records of lab experiments, standard operating procedures (SOPs), and data in hard copy laboratory notebooks, as well as in electronic versions made available to the PI and other individuals in the laboratory

Position Requirements

  • Graduate degree from an accredited institution of higher learning (major in science).
  • At least three (3) years of experience in biopharmaceutical manufacturing, quality analytics, biotechnology research and development or other area relevant research programs.
  • Ability to obtain/maintain an FDA security clearance and badge.

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