Job Description:
Midnight Sun Technologies, LLC

Researcher I
Department: Midnight Sun Technologies - FDA
Location: Silver Spring, MD, USA
Employment Type: Full Time

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 peer-reviewed scientific journals
• Maintain thorough and complete government-owned 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.

Apply online at our website: https://kikiktagruk.applicantpool.com/

Disclaimer: This is not to be an exclusive list of all responsibilities', duties, and skills required of the person in this job. KIC is an Equal Opportunity Employer. KIC considers all applicants for employment without regard to race, color, sex, national origin, religion, age, physical or mental disability, family responsibility, marital status, sexual orientation, political affiliation, veteran's status, gender identity or any other legal protected status. Pursuant to The Alaska Native Claims Settlement Act 43 U.S.C. Sec. 1601 et seq., and federal contractual requirements, Kikiktagruk Inupiat Corporation, may legally grant certain preference in employment opportunities to KIC Shareholders and their Descendants. EOE/AA/M/F/D/V. Please view Equal Employment Opportunity Posters provided by OFCCP here. Successful candidate must pass, comply and adhere to KIC's Drug and Alcohol policy/testing requirements and pass a thorough background check including fingerprinting.

PI240561001

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