Andrew Roth, Ph.D.
Research Writer and Regulatory Specialist at University of Colorado Anschutz Medical Campus- Claim this Profile
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Bio
Credentials
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SQL Essential Training
LinkedInAug, 2020- Oct, 2024 -
Collaborative Leadership
LinkedInJul, 2020- Oct, 2024 -
Certificate in Business
Texas A&M University - Mays Business SchoolMay, 2019- Oct, 2024
Experience
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University of Colorado Anschutz Medical Campus
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United States
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Higher Education
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700 & Above Employee
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Research Writer and Regulatory Specialist
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Jul 2021 - Present
Scientific and Regulatory Specialist for the Cellular Therapy Operations Program (CTOP). CTOP partners with CU Anschutz investigators and stakeholders to develop innovative Cellular Therapies and facilitates the regulatory, operational conduct and initiation of the related clinical trials. Scientific and Regulatory Specialist for the Cellular Therapy Operations Program (CTOP). CTOP partners with CU Anschutz investigators and stakeholders to develop innovative Cellular Therapies and facilitates the regulatory, operational conduct and initiation of the related clinical trials.
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CBR International Corp.
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United States
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Biotechnology Research
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1 - 100 Employee
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Scientist
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Nov 2020 - Jul 2021
Provided scientific expertise in regulatory strategy, product development, preclinical and clinical studies, and quality/GMP consulting to align clients with the regulatory authorities.Authored and reviewed regulatory documents like Investigational New Drug Applications (INDs), IND amendments, and New Drug Applications (NDAs) for submission to the regulatory authorities. Provided scientific expertise in regulatory strategy, product development, preclinical and clinical studies, and quality/GMP consulting to align clients with the regulatory authorities.Authored and reviewed regulatory documents like Investigational New Drug Applications (INDs), IND amendments, and New Drug Applications (NDAs) for submission to the regulatory authorities.
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University of Colorado Anschutz Medical Campus
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United States
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Higher Education
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700 & Above Employee
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Postdoctoral Researcher, Laboratory of Michael McMurray
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Jul 2020 - Nov 2020
Utilizing genetic and biochemical techniques to understand mechanisms of chaperone-assisted macromolecular complex formation with a focus on the septin proteins in yeast. Utilizing genetic and biochemical techniques to understand mechanisms of chaperone-assisted macromolecular complex formation with a focus on the septin proteins in yeast.
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Texas A&M University
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United States
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Higher Education
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700 & Above Employee
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PhD Candidate, Laboratory of Hays Rye
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Dec 2016 - Jun 2020
In vitro mechanistic studies of protein chaperones and their role in protein folding, protein aggregate structure, and protein aggregate disassembly. This is accomplished through the development of a fluorescence single particle approach known as Burst Analysis Spectroscopy (BAS). Other techniques used in these studies include protein characterization, ensemble FRET, electron microscopy, and UV-Vis spectroscopy.
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Graduate Research Assistant
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Aug 2014 - Jun 2020
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Calvin University
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United States
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Higher Education
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700 & Above Employee
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Research Assistant, Laboratory of David Benson
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May 2012 - Aug 2014
Biochemical protein research using advanced techniques in nuclear magnetic resonance (NMR), MALDI-TOF mass spectroscopy, and UV-Vis spectroscopy. Emphasis in structure function studies of post-translational modifications. Biochemical protein research using advanced techniques in nuclear magnetic resonance (NMR), MALDI-TOF mass spectroscopy, and UV-Vis spectroscopy. Emphasis in structure function studies of post-translational modifications.
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Education
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Texas A&M University
Doctor of Philosophy (PhD), Biochemistry -
Calvin College
Bachelor of Science (B.S.), Biochemistry