Daniel Rodriguez-Granrose, Phd, Psm Email and Phone Number
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Founder and CEO of Intactis Bio Corp, the Intact Tissue Bioengineering Corporation. Scientist with 14 years of industry experience; 3 years of executive experience; strong working knowledge of phase-appropriate CMC development from pre-IND through BLA/NDA, including regulatory interaction and Module 3 authorship across multiple stages of development, commercialization, and product classifications; experience working with multinational biopharma companies includes FDA, PMDA, EMA, and MHRA CMC development and tech transfer; extensive working knowledge of the nuances of DS/DP manufacture, analytical development, bioprocess development, and validation; proven track record building and managing technical teams across functions and organizations; commercialization of multiple cGMP products in leadership roles; expert communication with publications, technical presentations at major conferences, and years of experience as emcee to large crowds.Open to independent consulting.
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Founder And CeoIntactis Bio CorpSalt Lake City, Ut, Us
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Founder/CeoIntactis Bio Corp Feb 2024 - PresentSalt Lake City, Utah, United States•Built novel intact tissues, drug substance, drug product, process and tissue bioreactors, process controls, and analytical methods (patent pending)
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Sr. ConsultantDark Horse Consulting Group Inc. Dec 2021 - Feb 2024•Lead multifunctional stakeholders on the most efficient path to advance/de-risk CMC•Leveraged in-depth knowledge of ICH guidelines to write/transfer regulatory filings•Aided multiple groups in technical bioprocess development, management, and purchasing decisions. -
Sr. ManagerDiscgenics 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 DevelopmentDiscgenics Mar 2020 - Jan 2021Salt Lake City•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
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Senior Bioprocess ScientistDiscgenics Feb 2018 - Mar 2020Salt Lake City•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
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Biologist, Bioprocess Development And IndustrializationSanofi Oct 2015 - Jan 2018Athens, Ga• 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 IndustrializationSanofi Sep 2014 - Mar 2015Athens, Ga• Designed and refined bioprocesses for Department of Homeland Security • Planned and carried out upstream and downstream mammalian-ad5 bioreactor studies
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Bioprocessing And Biomanufacturing FellowThe University Of Georgia 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
Daniel Rodriguez-Granrose, Phd, Psm Skills
Daniel Rodriguez-Granrose, Phd, Psm Education Details
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Phd In Biochemistry And Molecular Biology -
(Track: Biopharma Management And Regulatory Affairs)
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Applied Biotechnology
Frequently Asked Questions about Daniel Rodriguez-Granrose, Phd, Psm
What company does Daniel Rodriguez-Granrose, Phd, Psm work for?
Daniel Rodriguez-Granrose, Phd, Psm works for Intactis Bio Corp
What is Daniel Rodriguez-Granrose, Phd, Psm's role at the current company?
Daniel Rodriguez-Granrose, Phd, Psm's current role is Founder and CEO.
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What schools did Daniel Rodriguez-Granrose, Phd, Psm attend?
Daniel Rodriguez-Granrose, Phd, Psm attended University Of Miami, The University Of Georgia, The University Of Georgia.
What are some of Daniel Rodriguez-Granrose, Phd, Psm's interests?
Daniel Rodriguez-Granrose, Phd, Psm has interest in Children, Health.
What skills is Daniel Rodriguez-Granrose, Phd, Psm known for?
Daniel Rodriguez-Granrose, Phd, Psm has skills like Pharmaceutical Sciences, Bioprocessing, Biotechnology, Research.
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