Kevin Sunley

Senior Process Scientist at Aeglea BioTherapeutics
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Contact Information
us****@****om
(386) 825-5501
Location
Austin, Texas, United States, US

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Experience

    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Senior Process Scientist
      • Jan 2023 - Jul 2023

      Austin, Texas, United States Manage and build relationships with external CDMOs, transferring technical knowledge, and lead development/optimization of process operations for GMP manufacturing of a therapeutic enzyme Process modeling, efficiency assessments, and implementing a multi-fold scale-up of upstream and downstream processes without impact to product quality or regulatory compliance Support the authoring of regulatory CMC submissions as the technical lead of clinical-stage therapeutic enzyme… Show more Manage and build relationships with external CDMOs, transferring technical knowledge, and lead development/optimization of process operations for GMP manufacturing of a therapeutic enzyme Process modeling, efficiency assessments, and implementing a multi-fold scale-up of upstream and downstream processes without impact to product quality or regulatory compliance Support the authoring of regulatory CMC submissions as the technical lead of clinical-stage therapeutic enzyme program Collaborative authoring with CMO partners, as well as internal review and approval of critical process documents, including GMP batch records, investigations and batch dispositions

    • Process Engineer
      • Jul 2019 - Apr 2023

      Austin, Texas Facilitated and supported activities related to development of upstream and downstream bioprocesses, technology transfers, process characterization, and process performance qualification of both drug substance and drug product of a PEGylated, multimeric therapeutic enzyme Ongoing support and process monitoring while working with external contract manufacturing organizations, identifying and ranking key process risks and implementing solutions to operations demonstrating sub-optimal… Show more Facilitated and supported activities related to development of upstream and downstream bioprocesses, technology transfers, process characterization, and process performance qualification of both drug substance and drug product of a PEGylated, multimeric therapeutic enzyme Ongoing support and process monitoring while working with external contract manufacturing organizations, identifying and ranking key process risks and implementing solutions to operations demonstrating sub-optimal efficiencies or performance

    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Principal Scientist
      • Jan 2015 - May 2019

      Austin, Texas Area Biophysical and biochemical characterization of therapeutic antibodies; including de novo protein amino acid sequencing, glycosylation, post-translational modifications and forced degradation analysis Providing direction to a research group involved in CHO cell bioprocess development, pilot-scale manufacturing and functional, biophysical and analytical protein characterization of novel therapeutic monoclonal antibodies and biosimilar molecules

    • Senior Scientist
      • Apr 2011 - Jan 2015

      Austin, Texas Area Developed strategies towards the isolation and characterization of human IgG molecules isolated from human patient blood samples with affinities to therapeutically important antigens. Provided direction to a research team involved in manufacture, purification and analysis of recombinant human, bacterial and viral antigens

    • Canada
    • Higher Education
    • 700 & Above Employee
    • Post-Doctoral Researcher
      • Apr 2009 - Apr 2011

      Winnipeg, Manitoba, Canada Developing procedures for the high-content characterization of novel monoclonal antibodies to generate validated biomarkers targeting mesenchymal stem cell transitions and disease pathologies relevant to our collaborators Linking traditional analytical tools (ELISAs, Western blots and immunoaffinity purifications) with automated high-content microscopy screening and MALDI-TOF mass spectrometry. These tools formed a platform which could identify previously unknown protein biomarkers… Show more Developing procedures for the high-content characterization of novel monoclonal antibodies to generate validated biomarkers targeting mesenchymal stem cell transitions and disease pathologies relevant to our collaborators Linking traditional analytical tools (ELISAs, Western blots and immunoaffinity purifications) with automated high-content microscopy screening and MALDI-TOF mass spectrometry. These tools formed a platform which could identify previously unknown protein biomarkers within minimal impact from experimental artifacts

    • Doctoral Student
      • Jan 2004 - Apr 2009

      Ph.D. Candidate in the Department of Microbiology under the supervision of Dr. Mike Butler. During my Ph.D. studies in the Department of Microbiology at the University of Manitoba, under the supervision of Dr. Mike Butler, I was involved in the development and scale-up of processes for the production of the recombinant human glycoproteins; investigating the effects of hypothermic culture conditions on product quality and the productivity of Chinese hamster ovary cells. To maximize… Show more Ph.D. Candidate in the Department of Microbiology under the supervision of Dr. Mike Butler. During my Ph.D. studies in the Department of Microbiology at the University of Manitoba, under the supervision of Dr. Mike Butler, I was involved in the development and scale-up of processes for the production of the recombinant human glycoproteins; investigating the effects of hypothermic culture conditions on product quality and the productivity of Chinese hamster ovary cells. To maximize the production of the recombinant protein, this project simultaneously optimized environmental conditions within the culture, the use of macroporous microcarriers for cell protection, and isolating a novel cell line capable of enhanced sub-physiological proliferation. This research was performed in flask-scale cell cultures as well as perfusion and batch pilot scale bioreactor experiments. Additional characterization was performed to ensure the final process produced a non-aggregated protein product with a glycosylation profile consistent with therapeutics already approved for clinical use.

Education

  • University of Manitoba
    Doctorate of Philosophy, Microbiology and Cell Culture Technology
    2004 - 2009
  • University of Manitoba
    B.Sc., Microbiology
    1997 - 2003

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