Daniel Rodriguez-Granrose, PhD, PSM

Sr. Consultant at Dark Horse Consulting Group Inc.
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Contact Information
us****@****om
(386) 825-5501
Location
Salt Lake City, Utah, United States, US
Languages
  • English Native or bilingual proficiency
  • Spanish Native or bilingual proficiency
  • Mandarin Chinese Elementary proficiency
  • French Elementary proficiency
  • Python & SQL Limited working proficiency

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Credentials

  • Graduate Certificate in Biopharma Regulatory Affairs
    University of Georgia College of Pharmacy
    Jul, 2014
    - Oct, 2024

Experience

  • Dark Horse Consulting Group Inc.
    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Sr. Consultant
      • Dec 2021 - Present

      •Lead multifunctional stakeholders on the most efficient path to advance/de-risk CMC •Leverage in-depth knowledge of ICH guidelines to write/transfer regulatory filings •Lead multifunctional stakeholders on the most efficient path to advance/de-risk CMC •Leverage in-depth knowledge of ICH guidelines to write/transfer regulatory filings

  • DiscGenics
    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Sr. Manager
      • Jan 2021 - Nov 2021

      •Lead bioprocess development; define, document, characterize, and ensure comparability between scales for the IDCT production process using a Quality by Design approach •Lead Phase I Process Validation and ensure regulatory compliance of the IDCT bioprocess by leading cross-functional Chemistry, Manufacturing, and Controls working group

    • Manager Bioprocess Development
      • Mar 2020 - Jan 2021

      •Devised and formally directed Quality by Design (QbD) bioprocess characterization, chemistry, manufacturing, and controls, including scientific rationale, >$2 mil budget, timeline, PD team (6.5 FTE), regulatory considerations, and coordination between functional groups •Drove bioinformatics intensive development with novel Design of Experiments (DOE), Artificial Intelligence, computational fluid dynamics, QbD, tissue culture, and bioprocess solutions

    • Senior Bioprocess Scientist
      • Feb 2018 - Mar 2020

      •Devised, executed, and analyzed “custom DOE” using attachment culture systems, stirred tank reactors, and JMP—accounting for variation between genetically distinct allogeneic cell lineages using true multi-dimensional design space •Developed scalable cell spheroid bioprocess from primary tissue to formulated cell therapy candidate as lead bioprocess scientist with 3 direct reports

  • Sanofi
    • France
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Biologist, Bioprocess Development and Industrialization
      • Oct 2015 - Jan 2018

      • Led bioprocess development for highest priority project; designed, operated, and optimized mammalian, insect, and viral processes from bench to industrial scale, ran 100s of bioreactors • Trained and led PhD level scientists on upstream and downstream processes as study director for 9 unique projects • Transferred successful processes from R&D to manufacturing • Led bioprocess development for highest priority project; designed, operated, and optimized mammalian, insect, and viral processes from bench to industrial scale, ran 100s of bioreactors • Trained and led PhD level scientists on upstream and downstream processes as study director for 9 unique projects • Transferred successful processes from R&D to manufacturing

    • Intern, Bioprocess Development and Industrialization
      • Sep 2014 - Mar 2015

      • Designed and refined bioprocesses for Department of Homeland Security • Planned and carried out upstream and downstream mammalian-ad5 bioreactor studies • Designed and refined bioprocesses for Department of Homeland Security • Planned and carried out upstream and downstream mammalian-ad5 bioreactor studies

  • The University of Georgia
    • Higher Education
    • 700 & Above Employee
    • Bioprocessing and Biomanufacturing Fellow
      • Aug 2009 - Aug 2014

      • Worked on mammalian cell culture and biofuel projects with industry partners at pilot scale bioprocess plant • Investigated the molecular basis of bacterial type II secretion using diverse genetic engineering techniques including plasmid, protein, and genetic network design • Selected from nationwide competition to conduct a 3-month, forensic phylobiology research study across China, Taiwan, and Japan as National Science Foundation Partners in International Research and Education Fellow • Worked on mammalian cell culture and biofuel projects with industry partners at pilot scale bioprocess plant • Investigated the molecular basis of bacterial type II secretion using diverse genetic engineering techniques including plasmid, protein, and genetic network design • Selected from nationwide competition to conduct a 3-month, forensic phylobiology research study across China, Taiwan, and Japan as National Science Foundation Partners in International Research and Education Fellow

Education

  • University of Miami
    PhD in Biochemistry and Molecular Biology
    2018 - 2021
  • The University of Georgia
    Professional Science Masters, (Track: Biopharma Management and Regulatory Affairs)
    2013 - 2014
  • The University of Georgia
    Bachelor of Science, Applied Biotechnology
    2009 - 2013

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