Kyle LaVigne
Associate Director of Pharmaceutical Development at Nocion Therapeutics, Inc.- Claim this Profile
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Bio
Experience
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Nocion Therapeutics, Inc.
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United States
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Biotechnology
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1 - 100 Employee
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Associate Director of Pharmaceutical Development
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Apr 2022 - Present
NOCION is a biopharmaceutical company that is addressing vexing medical problems head on. We are developing “nocions”—a new kind of therapy that selectively affects actively firing nociceptors—to provide targeted, robust and sustained relief for the treatment of serious conditions including cough, itch, pain and inflammation. At Nocion, I lead CMC and Quality activities at contract manufacturing organizations for the development of formulations (including dry powder inhalation, sterile… Show more NOCION is a biopharmaceutical company that is addressing vexing medical problems head on. We are developing “nocions”—a new kind of therapy that selectively affects actively firing nociceptors—to provide targeted, robust and sustained relief for the treatment of serious conditions including cough, itch, pain and inflammation. At Nocion, I lead CMC and Quality activities at contract manufacturing organizations for the development of formulations (including dry powder inhalation, sterile inhalation solution using Blow-Fill-Seal ampoules, metered dose inhalation, dermal gel, oral solid dose) to support pipeline of non-clinical to clinical-stage candidates using patented, charged sodium channel blocker NCEs.
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Senior Manager of Pharmaceutical Development
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Oct 2019 - Apr 2022
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Owner
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Nov 2021 - Present
I provide biopharmaceutical consulting to companies in need of pharmaceutical development, manufacturing, engineering, supply chain and quality assurance support.
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Manufacturing Manager
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Mar 2019 - Oct 2019
At Codiak Biosciences, we had a vision of making precision exosome therapeutics a reality. The company began with the singular focus of solving the engineering and manufacturing challenges to enable exosomes to deliver precise therapeutics in a targeted way for patient populations of any size. At Codiak, I managed technical and quality aspects of contract manufacturing organizations to meet clinical timelines for upstream, downstream processing as well as fill/finish operations for a… Show more At Codiak Biosciences, we had a vision of making precision exosome therapeutics a reality. The company began with the singular focus of solving the engineering and manufacturing challenges to enable exosomes to deliver precise therapeutics in a targeted way for patient populations of any size. At Codiak, I managed technical and quality aspects of contract manufacturing organizations to meet clinical timelines for upstream, downstream processing as well as fill/finish operations for a parenteral drug product. I also led the organizational efforts to bring manufacturing capabilities internal including facility design, facility build out, and quality management system start up. Show less
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Manager Process Development and Technology
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Sep 2016 - Feb 2019
Acorda’s mission is to develop therapies that restore function and improve the lives of people with neurological disorders. At Acorda, I was leader within a CMC team from clinical development phase through commercial NDA submission, culminating in successful FDA licensure of a combination drug product (Inbrija). I was responsible for the pharmaceutical development, tech transfer and GMP manufacturing from pre-clinical through commercial manufacturing for all pipeline inhalation drug… Show more Acorda’s mission is to develop therapies that restore function and improve the lives of people with neurological disorders. At Acorda, I was leader within a CMC team from clinical development phase through commercial NDA submission, culminating in successful FDA licensure of a combination drug product (Inbrija). I was responsible for the pharmaceutical development, tech transfer and GMP manufacturing from pre-clinical through commercial manufacturing for all pipeline inhalation drug products. Show less
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Acorda Therapeutics, Inc.
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United States
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Biotechnology Research
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100 - 200 Employee
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Process Engineer II
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Nov 2015 - Aug 2016
Greater Boston Area
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Process Engineer
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Mar 2014 - Nov 2015
Greater Boston Area
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Research Engineer
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Sep 2012 - Mar 2014
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Manufacturing Research Intern
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May 2011 - Aug 2011
Chelsea, MA
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Education
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Rensselaer Polytechnic Institute
Bachelor of Science (B.S.), Chemical Engineering